No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00389701006796 | RSC01 | RSC01 | DESTINATION Carotid Guiding Sheath | DYB | INTRODUCER, CATHETER | 2 | DESTINATION |
2 | 00389701007199 | RSR20 | RSR20 | DESTINATION Renal Guiding Sheath | DYB | INTRODUCER, CATHETER | 2 | DESTINATION |
3 | 00389701007182 | RSR18 | RSR18 | DESTINATION Renal Guiding Sheath | DYB | INTRODUCER, CATHETER | 2 | DESTINATION |
4 | 00389701007175 | RSR16 | RSR16 | DESTINATION Renal Guiding Sheath | DYB | INTRODUCER, CATHETER | 2 | DESTINATION |
5 | 00389701007168 | RSR14 | RSR14 | DESTINATION Renal Guiding Sheath | DYB | INTRODUCER, CATHETER | 2 | DESTINATION |
6 | 00389701007007 | RSR19 | RSR19 | DESTINATION Renal Guiding Sheath | DYB | INTRODUCER, CATHETER | 2 | DESTINATION |
7 | 00389701006994 | RSR17 | RSR17 | DESTINATION Renal Guiding Sheath | DYB | INTRODUCER, CATHETER | 2 | DESTINATION |
8 | 00389701006987 | RSR15 | RSR15 | DESTINATION Renal Guiding Sheath | DYB | INTRODUCER, CATHETER | 2 | DESTINATION |
9 | 00389701006970 | RSR13 | RSR13 | DESTINATION Renal Guiding Sheath | DYB | INTRODUCER, CATHETER | 2 | DESTINATION |
10 | 00389701006802 | RSC02 | RSC02 | DESTINATION Carotid Guiding Sheath | DYB | INTRODUCER, CATHETER | 2 | DESTINATION |
11 | 00389701012124 | 80-1670 | 80-1670 | GLIDESHEATH SLENDER Stainless Steel Kit | DYB | INTRODUCER, CATHETER | GLIDESHEATH SLENDER | |
12 | 00389701012117 | 80-1660 | 80-1660 | GLIDESHEATH SLENDER Stainless Steel Kit | DYB | INTRODUCER, CATHETER | 2 | GLIDESHEATH SLENDER |
13 | 00389701012100 | 80-1650 | 80-1650 | GLIDESHEATH SLENDER Stainless Steel Kit | DYB | INTRODUCER, CATHETER | GLIDESHEATH SLENDER | |
14 | 00389701012094 | 80-1075 | 80-1075 | GLIDESHEATH SLENDER Stainless Steel Kit | DYB | INTRODUCER, CATHETER | 2 | GLIDESHEATH SLENDER |
15 | 00389701012087 | 80-1070 | 80-1070 | GLIDESHEATH SLENDER Stainless Steel Kit | DYB | INTRODUCER, CATHETER | GLIDESHEATH SLENDER | |
16 | 00389701012070 | 80-1065 | 80-1065 | GLIDESHEATH SLENDER Stainless Steel Kit | DYB | INTRODUCER, CATHETER | 2 | GLIDESHEATH SLENDER |
17 | 00389701012063 | 80-1060 | 80-1060 | GLIDESHEATH SLENDER Stainless Steel Kit | DYB | INTRODUCER, CATHETER | 2 | GLIDESHEATH SLENDER |
18 | 00389701012056 | 80-1055 | 80-1055 | GLIDESHEATH SLENDER Stainless Steel Kit | DYB | INTRODUCER, CATHETER | GLIDESHEATH SLENDER | |
19 | 00389701012049 | 80-1050 | 80-1050 | GLIDESHEATH SLENDER Stainless Steel Kit | DYB | INTRODUCER, CATHETER | 2 | GLIDESHEATH SLENDER |
20 | 00389701012032 | 60-1670 | 60-1670 | GLIDESHEATH SLENDER Access Kit | DYB | INTRODUCER, CATHETER | 2 | GLIDESHEATH SLENDER |
21 | 00389701012025 | 60-1660 | 60-1660 | GLIDESHEATH SLENDER Access Kit | DYB | INTRODUCER, CATHETER | GLIDESHEATH SLENDER | |
22 | 00389701012018 | 60-1650 | 60-1650 | GLIDESHEATH SLENDER Access Kit | DYB | INTRODUCER, CATHETER | GLIDESHEATH SLENDER | |
23 | 00389701012001 | 60-1075 | 60-1075 | GLIDESHEATH SLENDER Access Kit | DYB | INTRODUCER, CATHETER | GLIDESHEATH SLENDER | |
24 | 00389701011998 | 60-1070 | 60-1070 | GLIDESHEATH SLENDER Access Kit | DYB | INTRODUCER, CATHETER | 2 | GLIDESHEATH SLENDER |
25 | 00389701011981 | 60-1065 | 60-1065 | GLIDESHEATH SLENDER Access Kit | DYB | INTRODUCER, CATHETER | GLIDESHEATH SLENDER | |
26 | 00389701011974 | 60-1060 | 60-1060 | GLIDESHEATH SLENDER Access Kit | DYB | INTRODUCER, CATHETER | 2 | GLIDESHEATH SLENDER |
27 | 00389701011967 | 60-1055 | 60-1055 | GLIDESHEATH SLENDER Access Kit | DYB | INTRODUCER, CATHETER | GLIDESHEATH SLENDER | |
28 | 00389701011950 | 60-1050 | 60-1050 | GLIDESHEATH SLENDER Access Kit | DYB | INTRODUCER, CATHETER | 2 | GLIDESHEATH SLENDER |
29 | 00389701011370 | 50-1070 | 50-1070 | GLIDESHEATH SLENDER Nitinol Hydrophilic Coated Introducer Sheath | DYB | INTRODUCER, CATHETER | GLIDESHEATH SLENDER | |
30 | 00389701011363 | 50-1050 | 50-1050 | GLIDESHEATH SLENDER Nitinol Hydrophilic Coated Introducer Sheath | DYB | INTRODUCER, CATHETER | 2 | GLIDESHEATH SLENDER |
31 | 00389701011332 | 50-1060 | 50-1060 | GLIDESHEATH SLENDER Nitinol Hydrophilic Coated Introducer Sheath | DYB | INTRODUCER, CATHETER | 2 | GLIDESHEATH SLENDER |
32 | 00389701009469 | 54-89006 | 54-89006 | DESTINATION Peripheral Guiding Sheath | DYB | INTRODUCER, CATHETER | 2 | DESTINATION |
33 | 00389701009452 | 54-89001 | 54-89001 | DESTINATION Peripheral Guiding Sheath | DYB | INTRODUCER, CATHETER | 2 | DESTINATION |
34 | 00389701009445 | 54-86506 | 54-86506 | DESTINATION Peripheral Guiding Sheath | DYB | INTRODUCER, CATHETER | 2 | DESTINATION |
35 | 00389701009438 | 54-86501 | 54-86501 | DESTINATION Peripheral Guiding Sheath | DYB | INTRODUCER, CATHETER | 2 | DESTINATION |
36 | 00389701009421 | 54-84506 | 54-84506 | DESTINATION Peripheral Guiding Sheath | DYB | INTRODUCER, CATHETER | 2 | DESTINATION |
37 | 00389701009414 | 54-84501 | 54-84501 | DESTINATION Peripheral Guiding Sheath | DYB | INTRODUCER, CATHETER | 2 | DESTINATION |
38 | 00389701008950 | 54-54505 | 54-54505 | DESTINATION Renal Guiding Sheath | DYB | INTRODUCER, CATHETER | 2 | DESTINATION |
39 | 00389701008943 | 54-54504 | 54-54504 | DESTINATION Renal Guiding Sheath | DYB | INTRODUCER, CATHETER | 2 | DESTINATION |
40 | 00389701008936 | 54-54503 | 54-54503 | DESTINATION Renal Guiding Sheath | DYB | INTRODUCER, CATHETER | 2 | DESTINATION |
41 | 00389701008929 | 54-54502 | 54-54502 | DESTINATION Renal Guiding Sheath | DYB | INTRODUCER, CATHETER | 2 | DESTINATION |
42 | 00389701008912 | 54-54501 | 54-54501 | DESTINATION Peripheral Guiding Sheath | DYB | INTRODUCER, CATHETER | 2 | DESTINATION |
43 | 00389701008868 | 54-74506 | 54-74506 | DESTINATION Peripheral Guiding Sheath | DYB | INTRODUCER, CATHETER | 2 | DESTINATION |
44 | 00389701008851 | 54-74501 | 54-74501 | DESTINATION Peripheral Guiding Sheath | DYB | INTRODUCER, CATHETER | 2 | DESTINATION |
45 | 00389701008844 | 54-64506 | 54-64506 | DESTINATION Peripheral Guiding Sheath | DYB | INTRODUCER, CATHETER | 2 | DESTINATION |
46 | 00389701008837 | 54-64501 | 54-64501 | DESTINATION Peripheral Guiding Sheath | DYB | INTRODUCER, CATHETER | 2 | DESTINATION |
47 | 00389701007953 | RSM08 | RSM08 | GLIDEACCESS System Percutaneous Sheath Introducer Kit | DYB,FOZ,DQX | INTRODUCER, CATHETER,Catheter,intravascular,therapeutic,short-term less than 30 INTRODUCER, CATHETER,Catheter,intravascular,therapeutic,short-term less than 30 days,WIRE, GUIDE, CATHETER | GLIDEACCESS | |
48 | 00389701007946 | RSM07 | RSM07 | GLIDEACCESS System Percutaneous Sheath Introducer Kit | DQX,DYB,FOZ | WIRE, GUIDE, CATHETER,INTRODUCER, CATHETER,Catheter,intravascular,therapeutic,sh WIRE, GUIDE, CATHETER,INTRODUCER, CATHETER,Catheter,intravascular,therapeutic,short-term less than 30 days | GLIDEACCESS | |
49 | 00389701007939 | RSM06 | RSM06 | GLIDEACCESS System Percutaneous Sheath Introducer Kit | DQX,DYB,FOZ | WIRE, GUIDE, CATHETER,INTRODUCER, CATHETER,Catheter,intravascular,therapeutic,sh WIRE, GUIDE, CATHETER,INTRODUCER, CATHETER,Catheter,intravascular,therapeutic,short-term less than 30 days | 2 | GLIDEACCESS |
50 | 00389701007922 | RSM05 | RSM05 | GLIDEACCESS System Percutaneous Sheath Introducer Kit | DQX,FOZ,DYB | WIRE, GUIDE, CATHETER,Catheter,intravascular,therapeutic,short-term less than 30 WIRE, GUIDE, CATHETER,Catheter,intravascular,therapeutic,short-term less than 30 days,INTRODUCER, CATHETER | GLIDEACCESS |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | M729800612C0 | 800-612C | The VASCADE MVP Venous Vascular Closure System (VVCS) is intended to seal femora The VASCADE MVP Venous Vascular Closure System (VVCS) is intended to seal femoral veins with single or multiple access sites in one or both limbs at the completion of catheterization procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at vessel puncture sites to achieve hemostasis. For use with 6Fr to 12Fr (15F maximum outer diameter) introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm. | Cardiva VASCADE MVP VVCS 6-12F | CARDIVA MEDICAL, INC. | |
2 | M729700580I0 | 700-580I | The VASCADE VCS is intended to seal femoral vessel puncture sites at the complet The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 6F & 7F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm. | Cardiva VASCADE 6/7F VCS | CARDIVA MEDICAL, INC. | |
3 | M729700500DX0 | 700-500DX | The VASCADE VCS is intended to seal femoral vessel puncture sites at the complet The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 5F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm. | Cardiva VASCADE 5F VCS | CARDIVA MEDICAL, INC. | |
4 | 10862028000434 | MX6760 | MX6760 | Mynx Control VCD 6F 7F | MYNX CONTROL | ACCESS CLOSURE, INC. |
5 | 10862028000427 | MX5060 | MX5060 | Mynx Control VCD 5F | MYNX CONTROL | ACCESS CLOSURE, INC. |
6 | 10862028000410 | MX6721 | MX6721 | MynxGrip 6F/7F | MYNXGRIP | ACCESS CLOSURE, INC. |
7 | 10862028000403 | MX5021 | MX5021 | MynxGrip 5F | MYNXGRIP | ACCESS CLOSURE, INC. |
8 | 10857141005251 | 202704 | 202704 | Closer Vascular Sealing System | REX MEDICAL LLP | |
9 | 10705032058896 | EX700 | EX700 | Cordis ExoSeal Vascular Closure Device | CORDIS CORPORATION | |
10 | 10705032058872 | EX500 | EX500 | Cordis ExoSeal Vascular Closure Device | CORDIS CORPORATION | |
11 | 10705032058858 | EX600 | EX600 | Cordis ExoSeal Vascular Closure Device | CORDIS CORPORATION | |
12 | M465MX67400 | MX6740 | MX6740 | Mynx Ace Vascular Closure Device (6F/7F) | Mynx Ace Vascular Closure Device (6F/7F) | ACCESS CLOSURE, INC. |
13 | M465MX67210 | MX6721 | MX6721 | MynxGrip Vascular Closure Device (6F/7F) | MynxGrip Vascular Closure Device (6F/7F) | ACCESS CLOSURE, INC. |
14 | M465MX50210 | MX5021 | MX5021 | MynxGrip Vascular Closure Device (5F) | MynxGrip Vascular Closure Device (5F) | ACCESS CLOSURE, INC. |
15 | 08717648235184 | 12773-03 | 12773-03 | Perclose™ ProStyle™ Suture-Mediated Closure and Repair System | Perclose™ ProStyle™ | ABBOTT VASCULAR INC. |
16 | 08717648175060 | 14679-05 | 14679-05 | STARCLOSE SE VCS WHITE SHEATH US | STARCLOSE SE | ABBOTT VASCULAR INC. |
17 | 08717648079467 | 14679-01 | 14679-01 | STARCLOSE SE Vascular Closure System | STARCLOSE SE | ABBOTT VASCULAR INC. |
18 | 08717648013089 | 12673-03 | 12673-03 | Perclose ProGlide™ Suture-Mediated Closure System | Perclose ProGlide™ | ABBOTT VASCULAR INC. |
19 | 08717648013065 | 12337-04 | 12337-04 | PERCLOSE A-T 6F Suture-Medicated Closure System | PERCLOSE | ABBOTT VASCULAR INC. |
20 | 08717648000621 | 12322-01 | 12322-01 | PROSTAR XL10F Percutaneous Vascular Surgical System | Prostar | ABBOTT VASCULAR INC. |
21 | 05415067002877 | STS Plus | 610121 | Angio-Seal™ | ST. JUDE MEDICAL CARDIOVASCULAR DIVISION | |
22 | 05415067002860 | STS Plus | 610119 | Angio-Seal™ | ST. JUDE MEDICAL CARDIOVASCULAR DIVISION | |
23 | 05415067002853 | VIP | 610131 | Angio-Seal™ | ST. JUDE MEDICAL CARDIOVASCULAR DIVISION | |
24 | 05415067002846 | Evolution™ | C610135 | Angio-Seal™ | ST. JUDE MEDICAL CARDIOVASCULAR DIVISION | |
25 | 05415067002839 | Evolution™ | C610134 | Angio-Seal™ | ST. JUDE MEDICAL CARDIOVASCULAR DIVISION | |
26 | 05414734054591 | VIP | 610130 | Angio-Seal™ | ST. JUDE MEDICAL CARDIOVASCULAR DIVISION | |
27 | 05391530280150 | KCLT-07 | Celt ACD Vascular Closure Device 7F_ESP | Celt ACD Vascular Closure Device 7F_ESP | VASORUM LIMITED | |
28 | 05391530280129 | KCLT-07 | Celt ACD Vascular Closure Device 7F | Celt ACD Vascular Closure Device 7F | VASORUM LIMITED | |
29 | 05391530280099 | KCLT-06 | Celt ACD Vascular Closure Device 6F_ESP | Celt ACD Vascular Closure Device 6F_ESP | VASORUM LIMITED | |
30 | 05391530280068 | KCLT-06 | Celt ACD Vascular Closure Device 6F | Celt ACD Vascular Closure Device 6F | VASORUM LIMITED | |
31 | 05391530280037 | KCLT-05 | Celt ACD Vascular Closure Device 5F_ESP | Celt ACD Vascular Closure Device 5F_ESP | VASORUM LIMITED | |
32 | 04719872920380 | 002 | 002 | The Cross-Seal Accessories (Cross-Seal Knot Tyer, Cross-Seal Knot Pusher, and Cr The Cross-Seal Accessories (Cross-Seal Knot Tyer, Cross-Seal Knot Pusher, and Cross-Seal Suture Trimmer) are designed to tie the knots, position the knot to the top of the arteriotomy, and to trim the trailing limbs of the suture, respectively. | Cross-Seal | MEDEON BIODESIGN, INC. |
33 | 04719872920359 | 002 | 002 | The Cross-Seal Device is composed of a Catheter, Suture Delivery System, and Han The Cross-Seal Device is composed of a Catheter, Suture Delivery System, and Handle.The Cross-Seal Device tracks over a standard 0.038” or 0.035” (minimum length 130 cm) guidewire. A hemostasis valve located in the middle of the CATHETER limits blood flow from the GUIDEWIRE PORT through the CATHETER with or without the guidewire in place. The SUTURE DELIVERY SYSTEM contains NEEDLES, LOCATOR WINGS, and the NEEDLE BARREL that control suture placement around the arteriotomy. The HANDLE contains the SLIDER, BLEEDING INDICATOR, PLUNGER, RESET 1 BUTTON (SLIDER RETRACTOR), and RESET 2 BUTTON (LOCATOR WINGS RETRACTOR). The SLIDER triggers a mechanism that opens the LOCATOR WINGS and creates a sandwich configuration to stabilize the delivery system within the vessel wall. The BLEEDING INDICATOR connects to a lumen that has an intraluminal port positioned at the distal end of the Suture Delivery System to allow bleeding back to ensure Suture Delivery System is positioned properly in the femoral artery. The NEEDLE BARREL keeps the Cross-Seal Device from moving deeper inside the vessel, stabilizes the device once the LOCATOR WINGS are opened and retrieves the disengaged suture-carried NEEDLES. The PLUNGER triggers the NEEDLES to deploy sutures and simultaneously close the LOCATOR WINGS. The GUIDEWIRE GUIDE is the feature at distal handle portion which allows physician to practice coaxial insertion of device along guidewire if necessary. | Cross-Seal | MEDEON BIODESIGN, INC. |
34 | 00856279007246 | 188F | MANTA 8F Depth Locator | ESSENTIAL MEDICAL, INC. | ||
35 | 00856279007208 | 114F | MANTA 14F Depth Locator | ESSENTIAL MEDICAL, INC. | ||
36 | 00856279007079 | 2156 | 14F MANTA Vascular Closure Device | MANTA | ESSENTIAL MEDICAL, INC. | |
37 | 00856279007062 | 2115 | 18F MANTA Vascular Closure Device | MANTA | ESSENTIAL MEDICAL, INC. | |
38 | 00389701011868 | 610119 | 610119 | ANGIO-SEAL STS Plus Vascular Closure Device | ANGIO-SEAL | TERUMO MEDICAL CORPORATION |
39 | 00389701011851 | 610121 | 610121 | ANGIO-SEAL STS Plus Vascular Closure Device | ANGIO-SEAL | TERUMO MEDICAL CORPORATION |
40 | 00389701011820 | 610130 | 610130 | ANGIO-SEAL VIP Vascular Closure Device | ANGIO-SEAL | TERUMO MEDICAL CORPORATION |
41 | 00389701011813 | 610131 | 610131 | ANGIO-SEAL VIP Vascular Closure Device | ANGIO-SEAL | TERUMO MEDICAL CORPORATION |
42 | 00389701011783 | C610134 | C610134 | ANGIO-SEAL EVOLUTION Vascular Closure Device | ANGIO-SEAL | TERUMO MEDICAL CORPORATION |
43 | 00389701011776 | C610135 | C610135 | ANGIO-SEAL EVOLUTION Vascular Closure Device | ANGIO-SEAL | TERUMO MEDICAL CORPORATION |