No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00821684068588 | PRB35-05-080-120 | STENT PRB35-05-080-120 PROTEGE EF V08 | NIP | STENT, SUPERFICIAL FEMORAL ARTERY | 3 | Protégé EverFlex™ | |
2 | 00821684068625 | PRB35-05-120-120 | STENT PRB35-05-120-120 PROTEGE EF V08 | NIP | STENT, SUPERFICIAL FEMORAL ARTERY | 3 | Protégé EverFlex™ | |
3 | 00821684068618 | PRB35-05-120-080 | STENT PRB35-05-120-080 PROTEGE EF V08 | NIP | STENT, SUPERFICIAL FEMORAL ARTERY | 3 | Protégé EverFlex™ | |
4 | 00821684068601 | PRB35-05-100-120 | STENT PRB35-05-100-120 PROTEGE EF V08 | NIP | STENT, SUPERFICIAL FEMORAL ARTERY | 3 | Protégé EverFlex™ | |
5 | 00821684068595 | PRB35-05-100-080 | STENT PRB35-05-100-080 PROTEGE EF V08 | NIP | STENT, SUPERFICIAL FEMORAL ARTERY | 3 | Protégé EverFlex™ | |
6 | 00821684068571 | PRB35-05-080-080 | STENT PRB35-05-080-080 PROTEGE EF V08 | NIP,FGE | STENT, SUPERFICIAL FEMORAL ARTERY,CATHETER, BILIARY, DIAGNOSTIC | 2 | Protégé EverFlex™ | |
7 | 00821684068564 | PRB35-05-060-120 | STENT PRB35-05-060-120 PROTEGE EF V08 | NIP,FGE | STENT, SUPERFICIAL FEMORAL ARTERY,CATHETER, BILIARY, DIAGNOSTIC | 2 | Protégé EverFlex™ | |
8 | 00821684068557 | PRB35-05-060-080 | STENT PRB35-05-060-080 PROTEGE EF V08 | NIP,FGE | STENT, SUPERFICIAL FEMORAL ARTERY,CATHETER, BILIARY, DIAGNOSTIC | 2 | Protégé EverFlex™ | |
9 | 00821684068540 | PRB35-05-040-120 | STENT PRB35-05-040-120 PROTEGE EF V08 | NIP,FGE | STENT, SUPERFICIAL FEMORAL ARTERY,CATHETER, BILIARY, DIAGNOSTIC | 2 | Protégé EverFlex™ | |
10 | 00821684068533 | PRB35-05-040-080 | STENT PRB35-05-040-080 PROTEGE EF V08 | NIP,FGE | STENT, SUPERFICIAL FEMORAL ARTERY,CATHETER, BILIARY, DIAGNOSTIC | 2 | Protégé EverFlex™ | |
11 | 00821684068526 | PRB35-05-030-120 | STENT PRB35-05-030-120 PROTEGE EF V08 | NIP,FGE | STENT, SUPERFICIAL FEMORAL ARTERY,CATHETER, BILIARY, DIAGNOSTIC | 2 | Protégé EverFlex™ | |
12 | 00821684068519 | PRB35-05-030-080 | STENT PRB35-05-030-080 PROTEGE EF V08 | NIP,FGE | STENT, SUPERFICIAL FEMORAL ARTERY,CATHETER, BILIARY, DIAGNOSTIC | 2 | Protégé EverFlex™ | |
13 | 00821684068502 | PRB35-05-020-120 | STENT PRB35-05-020-120 PROTEGE EF V08 | NIP,FGE | STENT, SUPERFICIAL FEMORAL ARTERY,CATHETER, BILIARY, DIAGNOSTIC | 2 | Protégé EverFlex™ | |
14 | 00821684068496 | PRB35-05-020-080 | STENT PRB35-05-020-080 PROTEGE EF V08 | NIP,FGE | STENT, SUPERFICIAL FEMORAL ARTERY,CATHETER, BILIARY, DIAGNOSTIC | 2 | Protégé EverFlex™ | |
15 | 00821684066843 | AB14W040210150 | PTA AB14W040210150 NANOCROSS 014 V04 | LIT,DQY | Catheter, angioplasty, peripheral, transluminal,CATHETER, PERCUTANEOUS | 2 | NanoCross™ Elite | |
16 | 00821684066836 | AB14W040210090 | PTA AB14W040210090 NANOCROSS 014 V04 | LIT,DQY | Catheter, angioplasty, peripheral, transluminal,CATHETER, PERCUTANEOUS | 2 | NanoCross™ Elite | |
17 | 00821684066829 | AB14W040150150 | PTA AB14W040150150 NANOCROSS 014 V04 | DQY,LIT | CATHETER, PERCUTANEOUS,Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
18 | 00821684066812 | AB14W040150090 | PTA AB14W040150090 NANOCROSS 014 V04 | DQY,LIT | CATHETER, PERCUTANEOUS,Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
19 | 00821684066805 | AB14W040120150 | PTA AB14W040120150 NANOCROSS 014 V04 | DQY,LIT | CATHETER, PERCUTANEOUS,Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
20 | 00821684066799 | AB14W040120090 | PTA AB14W040120090 NANOCROSS 014 V04 | LIT,DQY | Catheter, angioplasty, peripheral, transluminal,CATHETER, PERCUTANEOUS | 2 | NanoCross™ Elite | |
21 | 00821684066768 | AB14W040080150 | PTA AB14W040080150 NANOCROSS 014 V04 | LIT,DQY | Catheter, angioplasty, peripheral, transluminal,CATHETER, PERCUTANEOUS | 2 | NanoCross™ Elite | |
22 | 00821684066751 | AB14W040080090 | PTA AB14W040080090 NANOCROSS 014 V04 | LIT,DQY | Catheter, angioplasty, peripheral, transluminal,CATHETER, PERCUTANEOUS | 2 | NanoCross™ Elite | |
23 | 00821684066720 | AB14W040040150 | PTA AB14W040040150 NANOCROSS 014 V04 | DQY,LIT | CATHETER, PERCUTANEOUS,Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
24 | 00821684066713 | AB14W040040090 | PTA AB14W040040090 NANOCROSS 014 V04 | DQY,LIT | CATHETER, PERCUTANEOUS,Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
25 | 00821684066706 | AB14W040020150 | PTA AB14W040020150 NANOCROSS 014 V04 | DQY,LIT | CATHETER, PERCUTANEOUS,Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
26 | 00821684066690 | AB14W040020090 | PTA AB14W040020090 NANOCROSS 014 V04 | DQY,LIT | CATHETER, PERCUTANEOUS,Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
27 | 00821684066607 | AB14W035080150 | PTA AB14W035080150 NANOCROSS 014 V04 | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
28 | 00821684066591 | AB14W035080090 | PTA AB14W035080090 NANOCROSS 014 V04 | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
29 | 00821684066522 | AB14W030210150 | PTA AB14W030210150 NANOCROSS 014 V04 | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
30 | 00821684066515 | AB14W030210090 | PTA AB14W030210090 NANOCROSS 014 V04 | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
31 | 00821684066508 | AB14W030150150 | PTA AB14W030150150 NANOCROSS 014 V04 | DQY,LIT | CATHETER, PERCUTANEOUS,Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
32 | 00821684066492 | AB14W030150090 | PTA AB14W030150090 NANOCROSS 014 V04 | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
33 | 00821684066485 | AB14W030120150 | PTA AB14W030120150 NANOCROSS 014 V04 | LIT,DQY | Catheter, angioplasty, peripheral, transluminal,CATHETER, PERCUTANEOUS | 2 | NanoCross™ Elite | |
34 | 00821684066478 | AB14W030120090 | PTA AB14W030120090 NANOCROSS 014 V04 | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
35 | 00821684066447 | AB14W030080150 | PTA AB14W030080150 NANOCROSS 014 V04 | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
36 | 00821684066409 | AB14W030040150 | PTA AB14W030040150 NANOCROSS 014 V04 | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
37 | 00821684066393 | AB14W030040090 | PTA AB14W030040090 NANOCROSS 014 V04 | LIT,DQY | Catheter, angioplasty, peripheral, transluminal,CATHETER, PERCUTANEOUS | 2 | NanoCross™ Elite | |
38 | 00821684066386 | AB14W030020150 | PTA AB14W030020150 NANOCROSS 014 V04 | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
39 | 00821684066379 | AB14W030020090 | PTA AB14W030020090 NANOCROSS 014 V04 | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
40 | 00821684066362 | AB14W025210150 | PTA AB14W025210150 NANOCROSS 014 V04 | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
41 | 00821684066355 | AB14W025210090 | PTA AB14W025210090 NANOCROSS 014 V04 | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
42 | 00821684066348 | AB14W025150150 | PTA AB14W025150150 NANOCROSS 014 V04 | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
43 | 00821684066331 | AB14W025150090 | PTA AB14W025150090 NANOCROSS 014 V04 | LIT,DQY | Catheter, angioplasty, peripheral, transluminal,CATHETER, PERCUTANEOUS | 2 | NanoCross™ Elite | |
44 | 00821684066324 | AB14W025120150 | PTA AB14W025120150 NANOCROSS 014 V04 | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
45 | 00821684066317 | AB14W025120090 | PTA AB14W025120090 NANOCROSS 014 V04 | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
46 | 00821684066287 | AB14W025080150 | PTA AB14W025080150 NANOCROSS 014 V04 | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
47 | 00821684066270 | AB14W025080090 | PTA AB14W025080090 NANOCROSS 014 V04 | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
48 | 00821684066249 | AB14W025040150 | PTA AB14W025040150 NANOCROSS 014 V04 | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
49 | 00821684066232 | AB14W025040090 | PTA AB14W025040090 NANOCROSS 014 V04 | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite | |
50 | 00821684066225 | AB14W025020150 | PTA AB14W025020150 NANOCROSS 014 V04 | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | NanoCross™ Elite |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00853989006170 | XC-035-145B | XC-035-145B | XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. | XableCath | ZIEN MEDICAL TECHNOLOGIES, INC. |
2 | 00853989006163 | XC-035-090B | XC-035-090B | XableCath is an over-th-wire catheter for facilitating guide wire and catheter a XableCath is an over-th-wire catheter for facilitating guide wire and catheter access in peripheral lesions. | XableCath | ZIEN MEDICAL TECHNOLOGIES, INC. |
3 | 00853989006156 | XC-018-145B | XC-018-145B | XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. | XableCath | ZIEN MEDICAL TECHNOLOGIES, INC. |
4 | 00853989006149 | XC-018-090B | XC-018-090B | XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. | XableCath | ZIEN MEDICAL TECHNOLOGIES, INC. |
5 | 00853989006132 | XC-014-145B | XC-014-145B | XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. | XableCath | ZIEN MEDICAL TECHNOLOGIES, INC. |
6 | 00853989006125 | XC-014-090B | XC-014-090B | XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. | XableCath | ZIEN MEDICAL TECHNOLOGIES, INC. |
7 | 00853989006118 | XC-035-065B | XC-035-065B | XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. | XableCath | ZIEN MEDICAL TECHNOLOGIES, INC. |
8 | 00853989006101 | XC-018-065B | XC-018-065B | XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. | XableCath | ZIEN MEDICAL TECHNOLOGIES, INC. |
9 | 00853989006095 | XC-014-065B | XC-014-065B | XableCath is an over the wire catheter for facilitating guide wire and catheter XableCath is an over the wire catheter for facilitating guide wire and catheter access to peripheral lesions. | XableCath | ZIEN MEDICAL TECHNOLOGIES, INC. |
10 | 00853989006088 | XC-035-145A | XC-035-145A | XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. | XableCath | ZIEN MEDICAL TECHNOLOGIES, INC. |
11 | 00853989006071 | XC-035-090A | XC-035-090A | XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. | XableCath | ZIEN MEDICAL TECHNOLOGIES, INC. |
12 | 00853989006064 | XC-035-065A | XC-035-065A | XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. | XableCath | ZIEN MEDICAL TECHNOLOGIES, INC. |
13 | 00853989006057 | XC-018-145A | XC-018-145A | XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. | XableCath | ZIEN MEDICAL TECHNOLOGIES, INC. |
14 | 00853989006040 | XC-018-090A | XC-018-090A | XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. | XableCath | ZIEN MEDICAL TECHNOLOGIES, INC. |
15 | 00853989006033 | XC-018-065A | XC-018-065A | XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. | XableCath | ZIEN MEDICAL TECHNOLOGIES, INC. |
16 | 00853989006026 | XC-014-145A | XC-014-145A | XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. | XableCath | ZIEN MEDICAL TECHNOLOGIES, INC. |
17 | 00853989006019 | XC-014-090A | XC-014-090A | XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. | XableCath | ZIEN MEDICAL TECHNOLOGIES, INC. |
18 | 00853989006002 | XC-014-065A | XC-014-065A | XableCath is an over-the-wire catheter for facilitating guide wire and catheter XableCath is an over-the-wire catheter for facilitating guide wire and catheter access in peripheral lesions. | XableCath | ZIEN MEDICAL TECHNOLOGIES, INC. |
19 | 00853892004447 | 120cm | 28-W1-50-08-120G | Aortic Balloon Catheter, 120cm | Terumo Aortic Balloon | QXMEDICAL |
20 | 00853892004287 | CAM-014-065 | CAM-014-065 | Support Catheter, 65 cm working length, compatible with 0.014" guidewires | Camaro Support Catheter | QXMEDICAL |
21 | 00853892004270 | CAM-014-090 | CAM-014-090 | Support Catheter, 90 cm working length, compatible with 0.014" guidewires | Camaro Support Catheter | QXMEDICAL |
22 | 00853892004263 | CAM-014-135 | CAM-014-135 | Support Catheter, 135 cm working length, compatible with 0.014" guidewires | Camaro Support Catheter | QXMEDICAL |
23 | 00853892004256 | CAM-014-150 | CAM-014-150 | Support Catheter, 150 cm working length, compatible with 0.014" guidewires | Camaro Support Catheter | QXMEDICAL |
24 | 00853892004249 | CAM-014-180 | CAM-014-180 | Support Catheter, 180 cm working length, compatible with 0.014" guidewires | Camaro Support Catheter | QXMEDICAL |
25 | 00853892004232 | CAM-018-065 | CAM-018-065 | Support Catheter, 65 cm working length, compatible with 0.018" guidewires | Camaro Support Catheter | QXMEDICAL |
26 | 00853892004225 | CAM-018-090 | CAM-018-090 | Support Catheter, 90 cm working length, compatible with 0.018" guidewires | Camaro Support Catheter | QXMEDICAL |
27 | 00853892004218 | CAM-018-135 | CAM-018-135 | Support Catheter, 135 cm working length, compatible with 0.018" guidewires | Camaro Support Catheter | QXMEDICAL |
28 | 00853892004201 | CAM-018-150 | CAM-018-150 | Support Catheter, 150 cm working length, compatible with 0.018" guidewires | Camaro Support Catheter | QXMEDICAL |
29 | 00853892004195 | CAM-018-180 | CAM-018-180 | Support Catheter, 180 cm working length, compatible with 0.018" guidewires | Camaro Support Catheter | QXMEDICAL |
30 | 00853892004188 | CAM-035-065 | CAM-035-065 | Support Catheter, 65 cm working length, compatible with 0.035" guidewires | Camaro Support Catheter | QXMEDICAL |
31 | 00853892004171 | CAM-035-090 | CAM-035-090 | Support Catheter, 90 cm working length, compatible with .035" guidewires | Camaro Support Catheter | QXMEDICAL |
32 | 00853892004164 | CAM-035-135 | CAM-035-135 | Support Catheter, 135 cm working length, compatible with 0.035" guidewires | Camaro Support Catheter | QXMEDICAL |
33 | 00853892004157 | CAM-035-150 | CAM-035-150 | Support Catheter, 150 cm working length, compatible with .035" guidewires | Camaro Support Catheter | QXMEDICAL |
34 | 00853892004140 | CAM-035-180 | CAM-035-180 | Support Catheter, 180cm effective length, compatible with 0.035" Guidewires | Camaro Support Catheter | QXMEDICAL |
35 | 00853892004089 | Q50-100-X | Q50-100-X | Q50X Stent Graft Balloon Catheter, 100cm | Q50X | QXMEDICAL |
36 | 00853892004072 | Q50-65-X | Q50-65-X | Q50X Stent Graft Balloon Catheter, 65cm | Q50X | QXMEDICAL |
37 | 00853892004058 | BC52-150 | BC52-150 | Support Catheter, .052" ID x 150cm | Boosting Catheter | QXMEDICAL |
38 | 00853892004041 | BC72-150 | BC72-150 | Support Catheter, .072" ID x 150cm | Boosting Catheter | QXMEDICAL |
39 | 00853892004034 | BC63-150 | BC63-150 | Support Catheter, .063" ID x 150cm | Boosting Catheter | QXMEDICAL |
40 | 00853892004027 | BC57-150 | BC57-150 | Support Catheter, .057" ID x 150cm | Boosting Catheter | QXMEDICAL |
41 | 00853892004010 | Q50-100P | Q50-100P | Q50 Plus Stent Graft Balloon Catheter, 100cm | Q50 Plus | QXMEDICAL |
42 | 00853892004003 | Q50-65P | Q50-65P | Q50 Plus Stent Graft Balloon Catheter, 65cm | Q50 Plus | QXMEDICAL |
43 | 00853799007404 | FD 0743 | REF 5001 | 8F Base Camp Sheath System | 8F Base Camp Sheath System | ROUTE 92 MEDICAL |
44 | 00853799007237 | FD 0475 | REF 1005 | Tenzing 7 Delivery Catheter | Tenzing 7 Delivery Catheter | ROUTE 92 MEDICAL |
45 | 00851354004189 | O200 | O200 | The Ocelot System is intended to facilitate the intraluminal placement of conven The Ocelot System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures. The Ocelot System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature. | Ocelot III | AVINGER, INC. |
46 | 00851354004073 | J100 | J100 | Juicebox is an optional accessory to facilitate catheter tip rotation when using Juicebox is an optional accessory to facilitate catheter tip rotation when using a compatible Avinger catheter. It consists of a handle with a Rotation Toggle Switch and a Release Button. Juicebox is designed to be placed over the catheter handle. This accessory is irradiated for sterility and is intended for single use only. When Juicebox is properly placed over a catheter handle, it locks into place. Depressing the Rotation Toggle Switch activates the power for rotation in either the clockwise or counterclockwise directions. The Release Button releases Juicebox so that it can be removed from the catheter handle.The Juicebox is an optional accessory that may be used to facilitate catheter tip rotation when using a compatible Avinger catheter. | Juicebox | AVINGER, INC. |
47 | 00851354004059 | E550 | E550 | "Kittycat 2 Catheter is a 5F sheath and 0.014” guidewire compatible over-the-wi "Kittycat 2 Catheter is a 5F sheath and 0.014” guidewire compatible over-the-wire device with a working length of 150 cm. It consists of a catheter shaft with handle assembly at the proximal end and an atraumatic Distal Tip. A locking Luer connecter at the proximal end provides entry to a lumen that supports and facilitates movement of a guidewire. The catheter has been irradiated for sterility and is intended for single use only.The Distal Tip houses Spiral Flutes and allows atraumatic advancement of the catheter through the vasculature. The pre-shaped Distal Tip is made of a malleable material and may be reshaped as needed by the user. The deflection of the Distal Tip is visible under fluoroscopic guidance.The handle assembly consists of a Handle Body, Rotator, and Luer. The Handle Body controls rotational orientation of the catheter, including the flexible Distal Tip. The Rotator controls the rotational movement of the Distal Tip, independent of the catheter orientation. The Luer is provided at the proximal end to facilitate fluid flush and the entry/exit of the guidewire. Kittycat 2 is intended to create a channel in totally occluded peripheral vessels. The device may also be used to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention. " | Kittykat II | AVINGER, INC. |
48 | 00851354004042 | W550` | W550 | "Kittycat 2 Catheter is a 5F sheath and 0.014” guidewire compatible over-the-wi "Kittycat 2 Catheter is a 5F sheath and 0.014” guidewire compatible over-the-wire device with a working length of 150 cm. It consists of a catheter shaft with handle assembly at the proximal end and an atraumatic Distal Tip. A locking Luer connecter at the proximal end provides entry to a lumen that supports and facilitates movement of a guidewire. The catheter has been irradiated for sterility and is intended for single use only.The Distal Tip houses Spiral Flutes and allows atraumatic advancement of the catheter through the vasculature. The pre-shaped Distal Tip is made of a malleable material and may be reshaped as needed by the user. The deflection of the Distal Tip is visible under fluoroscopic guidance.The handle assembly consists of a Handle Body, Rotator, and Luer. The Handle Body controls rotational orientation of the catheter, including the flexible Distal Tip. The Rotator controls the rotational movement of the Distal Tip, independent of the catheter orientation. The Luer is provided at the proximal end to facilitate fluid flush and the entry/exit of the guidewire. Kittycat 2 is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention. The Kittycat 2 Catheter is contraindicated for use in the iliac, coronary, cerebral or carotid vasculature.Kittycat 2 is intended to be used to support steerable guidewires in accessing discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. It may also be used to deliver saline or contrast." | Kittykat II | AVINGER, INC. |
49 | 00851354004028 | E400 | E400 | "The Wildcat CTO Catheter is intended to create a channel in totally occluded pe "The Wildcat CTO Catheter is intended to create a channel in totally occluded peripheral vessels. The device may also be used to faciliate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention. The Wildcat CTO Catheter is a 6F sheath and 0.035"" guidewire compatible over-the-wire device. It consists of a catheter shaft with a handle assembly at the porximal end and an atraumatic Distal Tip. A locking Luer connector at the proximal end provides entry to a lumen that supports and facilitates movement of a guidewire. The catheter has been irradiated for sterility and is intended for single use only. At the Slider’s most proximal location, the Wedges are in the retracted position. At the mid-point location, the Wedges are deployed. Moving the slider distal from this point initiates deflection of the Distal Tip. The amount of tip deflection increases with distal movement of the slider. At the most distal location, the Wedges remain fully deployed and the Distal Tip is at maximum deflection. The deployment and retraction of the Wedges as well as the deflection of the Distal Tip is visible under fluoroscopic guidance.The handle assembly consists of a Handle Body, Rotator, Tip Indicator, Slider, and Luer. The Handle Body controls rotational orientation of the catheter, including the flexible Distal Tip. The Rotator controls the rotational movement of the Distal Tip, independent of the catheter orientation. Rotational movement of the Distal Tip can be achieved either with Wedges deployed or retracted. Luer is provided to facilitate fluid flush and the entry/exit of the guidewire. " | Wildcat | AVINGER, INC. |
50 | 00851354004004 | W400 | W400 | "The Wildcat CTO Catheter is intended to create a channel in totally occluded pe "The Wildcat CTO Catheter is intended to create a channel in totally occluded peripheral vessels. The device may also be used to faciliate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention. The Wildcat Catheter is contraindicated for use in the iliac, coronary, cerebral or carotid vasculature. The Wildcat Catheter is intended to be used to support steerable guidewires in accessing discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices. It may also be used to deliver saline or contrast.The Wildcat CTO Catheter is a 6F sheath and 0.035"" guidewire compatible over-the-wire device. It consists of a catheter shaft with a handle assembly at the porximal end and an atraumatic Distal Tip. A locking Luer connector at the proximal end provides entry to a lumen that supports and facilitates movement of a guidewire. The catheter has been irradiated for sterility and is intended for single use only. At the Slider’s most proximal location, the Wedges are in the retracted position. At the mid-point location, the Wedges are deployed. Moving the slider distal from this point initiates deflection of the Distal Tip. The amount of tip deflection increases with distal movement of the slider. At the most distal location, the Wedges remain fully deployed and the Distal Tip is at maximum deflection. The deployment and retraction of the Wedges as well as the deflection of the Distal Tip is visible under fluoroscopic guidance. | Wildcat | AVINGER, INC. |