No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00813132020187 | 425-011AA | 425-011 | Turbo-Elite™ Laser Atherectomy Catheter | MCW | Catheter, Peripheral, Atherectomy | 2 | Turbo-Elite™ |
2 | 00813132020170 | 423-001AA | 423-001 | Turbo-Elite™ Laser Atherectomy Catheter | MCW | Catheter, Peripheral, Atherectomy | 2 | Turbo-Elite™ |
3 | 00813132020163 | 420-159AA | 420-159 | Turbo-Elite™ Laser Atherectomy Catheter | MCW | Catheter, Peripheral, Atherectomy | 2 | Turbo-Elite™ |
4 | 00813132020156 | 420-006AA | 420-006 | Turbo-Elite™ Laser Atherectomy Catheter | MCW | Catheter, Peripheral, Atherectomy | 2 | Turbo-Elite™ |
5 | 00813132020149 | 417-156AA | 417-156 | Turbo-Elite™ Laser Atherectomy Catheter | MCW | Catheter, Peripheral, Atherectomy | 2 | Turbo-Elite™ |
6 | 00813132020132 | 417-152AA | 417-152 | Turbo-Elite™ Laser Atherectomy Catheter | MCW | Catheter, Peripheral, Atherectomy | 2 | Turbo-Elite™ |
7 | 00813132020125 | 414-159AA | 414-159 | Turbo-Elite™ Laser Atherectomy Catheter | MCW | Catheter, Peripheral, Atherectomy | 2 | Turbo-Elite™ |
8 | 00813132020118 | 414-151AA | 414-151 | Turbo-Elite™ Laser Atherectomy Catheter | MCW | Catheter, Peripheral, Atherectomy | 2 | Turbo-Elite™ |
9 | 00813132020101 | 410-154AA | 410-154 | Turbo-Elite™ Laser Atherectomy Catheter | MCW | Catheter, Peripheral, Atherectomy | 2 | Turbo-Elite™ |
10 | M2045180390 | 518-039 | 518-039 | Lead Locking Device (LLD E) | DRB | Stylet, Catheter | 2 | LLD™E |
11 | M2044250010 | 425-011 | 425-011 | Turbo-Elite™ Laser Atherectomy Catheter | MCW | Catheter, Peripheral, Atherectomy | 2 | Turbo-Elite™ |
12 | M2044230010 | 423-001 | 423-001 | Turbo-Elite™ Laser Atherectomy Catheter | MCW | Catheter, Peripheral, Atherectomy | 2 | Turbo-Elite™ |
13 | M2044201590 | 420-159 | 420-159 | Turbo-Elite™ Laser Atherectomy Catheter | MCW | Catheter, Peripheral, Atherectomy | 2 | Turbo-Elite™ |
14 | M2044200060 | 420-006 | 420-006 | Turbo-Elite™ Laser Atherectomy Catheter | MCW | Catheter, Peripheral, Atherectomy | 2 | Turbo-Elite™ |
15 | M2044171560 | 417-156 | 417-156 | Turbo-Elite™ Laser Atherectomy Catheter | MCW | Catheter, Peripheral, Atherectomy | 2 | Turbo-Elite™ |
16 | M2044171520 | 417-152 | 417-152 | Turbo-Elite™ Laser Atherectomy Catheter | MCW | Catheter, Peripheral, Atherectomy | 2 | Turbo-Elite™ |
17 | M2044141590 | 414-159 | 414-159 | Turbo-Elite™ Laser Atherectomy Catheter | MCW | Catheter, Peripheral, Atherectomy | 2 | Turbo-Elite™ |
18 | M2044141510 | 414-151 | 414-151 | Turbo-Elite™ Laser Atherectomy Catheter | MCW | Catheter, Peripheral, Atherectomy | 2 | Turbo-Elite™ |
19 | M2044101540 | 410-154 | 410-154 | Turbo-Elite™ Laser Atherectomy Catheter | MCW | Catheter, Peripheral, Atherectomy | 2 | Turbo-Elite™ |
20 | M2044101520 | 410-152 | 410-152 | Turbo-Elite™ Laser Atherectomy Catheter | MCW | Catheter, Peripheral, Atherectomy | 2 | Turbo-Elite™ |
21 | 00813132020477 | 518-078AA | 518-078 | Quick-Cross™Extreme™ Support Catheter | DQY | Catheter, Percutaneous | Quick-Cross™Extreme™ | |
22 | 00813132020460 | 518-077AA | 518-077 | Quick-Cross™Select Support Catheter | DQY | Catheter, Percutaneous | Quick-Cross™Select | |
23 | 00813132020453 | 518-076AA | 518-076 | Quick-Cross™Extreme™ Support Catheter | DQY | Catheter, Percutaneous | Quick-Cross™Extreme™ | |
24 | 00813132020316 | 500-013AA | 500-013 | SLS™II Laser Sheath | MFA | Device, Removal, Pacemaker Electrode, Percutaneous | 3 | SLS™II |
25 | 00813132020309 | 500-012AA | 500-012 | SLS™II Laser Sheath | MFA | Device, Removal, Pacemaker Electrode, Percutaneous | 3 | SLS™II |
26 | 00813132020293 | 500-001AA | 500-001 | SLS™II Laser Sheath | MFA | Device, Removal, Pacemaker Electrode, Percutaneous | 3 | SLS™II |
27 | 00813132024970 | AB35SX040100080 | AB35SX040100080 | Stellarex™ 0.035 OTW Drug-coated Angioplasty Balloon | ONU | Drug-Eluting Peripheral Transluminal Angioplasty Catheter | 3 | Stellarex™ |
28 | 00813132024840 | 590-001AB | 590-001 | Bridge Occlusion Catheter - 80 mm Length Balloon | MJN | Catheter, Intravascular Occluding, Temporary | 2 | Bridge™ |
29 | 00813132024666 | 590-001AA | 590-001 | Bridge Occlusion Catheter - 80 mm Length Balloon | MJN | Catheter, Intravascular Occluding, Temporary | 2 | Bridge™ |
30 | 00813132022259 | 518-076AB | 518-076 | Quick-Cross™Extreme™ Support Catheter | DQY | Catheter, Percutaneous | Quick-Cross™Extreme™ | |
31 | 00813132020941 | 555-508AA | 555-508 | SightRail™ Manual Dilator Sheath | DRE | Dilator, Vessel, For Percutaneous Catheterization | 2 | SightRail™ |
32 | 00813132021795 | 518-093AB | 518-093 | Quick-Cross™Select Support Catheter | DQY | Catheter, Percutaneous | Quick-Cross™Select | |
33 | 00813132021788 | 518-092AB | 518-092 | Quick-Cross™Extreme™ Support Catheter | DQY | Catheter, Percutaneous | Quick-Cross™Extreme™ | |
34 | 00813132021771 | 518-091AB | 518-091 | Quick-Cross™Select Support Catheter | DQY | Catheter, Percutaneous | Quick-Cross™Select | |
35 | 00813132021764 | 518-090AB | 518-090 | Quick-Cross™Extreme™ Support Catheter | DQY | Catheter, Percutaneous | Quick-Cross™Extreme™ | |
36 | 00813132021757 | 518-089AB | 518-089 | Quick-Cross™Select Support Catheter | DQY | Catheter, Percutaneous | Quick-Cross™Select | |
37 | 00813132021740 | 518-088AB | 518-088 | Quick-Cross™Extreme™ Support Catheter | DQY | Catheter, Percutaneous | Quick-Cross™Extreme™ | |
38 | 00813132021733 | 518-087AB | 518-087 | Quick-Cross™Select Support Catheter | DQY | Catheter, Percutaneous | Quick-Cross™Select | |
39 | 00813132021726 | 518-086AB | 518-086 | Quick-Cross™Extreme™ Support Catheter | DQY | Catheter, Percutaneous | Quick-Cross™Extreme™ | |
40 | 00813132021719 | 518-085AB | 518-085 | Quick-Cross™Select Support Catheter | DQY | Catheter, Percutaneous | Quick-Cross™Select | |
41 | 00813132021702 | 518-084AB | 518-084 | Quick-Cross™Extreme™ Support Catheter | DQY | Catheter, Percutaneous | Quick-Cross™Extreme™ | |
42 | 00813132021696 | 518-083AB | 518-083 | Quick-Cross™Select Support Catheter | DQY | Catheter, Percutaneous | Quick-Cross™Select | |
43 | 00813132021689 | 518-082AB | 518-082 | Quick-Cross™Extreme™ Support Catheter | DQY | Catheter, Percutaneous | Quick-Cross™Extreme™ | |
44 | 00813132021672 | 518-081AB | 518-081 | Quick-Cross™Select Support Catheter | DQY | Catheter, Percutaneous | Quick-Cross™Select | |
45 | 00813132021665 | 518-080AB | 518-080 | Quick-Cross™Extreme™ Support Catheter | DQY | Catheter, Percutaneous | Quick-Cross™Extreme™ | |
46 | 00813132021481 | 518-079AB | 518-079 | Quick-Cross™Select Support Catheter | DQY | Catheter, Percutaneous | Quick-Cross™Select | |
47 | 00813132021474 | 518-078AB | 518-078 | Quick-Cross™Extreme™ Support Catheter | DQY | Catheter, Percutaneous | Quick-Cross™Extreme™ | |
48 | 00813132021467 | 518-077AB | 518-077 | Quick-Cross™Select Support Catheter | DQY | Catheter, Percutaneous | Quick-Cross™Select | |
49 | 00813132020996 | 519-106AA | 519-106 | Quick-Cross™ Capture™ Guidewire Retriever | DQY | Catheter, Percutaneous | 2 | Quick-Cross™ Capture™ |
50 | 00813132020972 | 555-513AA | 555-513 | SightRail™ Manual Dilator Sheath | DRE | Dilator, Vessel, For Percutaneous Catheterization | 2 | SightRail™ |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00851354004417 | A140-SV | A140-SV | The Pantheris SV System is intended to remove plaque (atherectomy) from partiall The Pantheris SV System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 2.0 mm to 4.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies. | Pantheris SV | AVINGER, INC. |
2 | 00851354004387 | A400X | A400X | The Pantheris System is intended to remove plaque (atherectomy) from partially o The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 3.0 mm to 7.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies. | Pantheris | AVINGER, INC. |
3 | 00851354004370 | A400 | A400 | The Pantheris System is intended to remove plaque (atherectomy) from partially o The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 3.0 mm to 7.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies. | Pantheris | AVINGER, INC. |
4 | 00845225003197 | PD24130K | PHOENIX ATHERECTOMY DEFLECTING SYSTEM, 2.4MM X 130CM, 7F | VOLCANO ATHEROMED, INC. | ||
5 | 00845225003180 | PD24130 | PHOENIX ATHERECTOMY DEFLECTING CATHETER, 2.4MM X 130CM, 7F | VOLCANO ATHEROMED, INC. | ||
6 | 00845225003173 | P15149K | PHOENIX ATHERECTOMY SYSTEM, 1.5MM X 149CM, 4F | VOLCANO ATHEROMED, INC. | ||
7 | 00845225003166 | P15149 | PHOENIX ATHERECTOMY CATHETER, 1.5MM X 149CM, 4F | VOLCANO ATHEROMED, INC. | ||
8 | 00845225002992 | PD22130K | PD22130K | Model number FG3431 | Phoenix Atherectomy Deflecting System , 2.2mm X 130cm 6F | VOLCANO ATHEROMED, INC. |
9 | 00845225002985 | PD22130 | PD22130 | Internal Model Number FG3061 | Phoenix Deflecting Atherectomy Catheter, 2.2mm X 130cm , 6F | VOLCANO ATHEROMED, INC. |
10 | 00845225002978 | P24130K | Phoenix Atherectomy System, 2.4mm X 130cm, 7F | VOLCANO ATHEROMED, INC. | ||
11 | 00845225002961 | P24130 | Phoenix Atherectomy Catheter, 2.4mm X 130cm, 7F | VOLCANO ATHEROMED, INC. | ||
12 | 00845225002732 | P22149K | Phoenix Atherectomy System, 2.2mm X 149cm Kit | VOLCANO ATHEROMED, INC. | ||
13 | 00845225002725 | P18149K | Phoenix Atherectomy System, 1.8mm X 149cm Kit | VOLCANO ATHEROMED, INC. | ||
14 | 00845225002718 | PD24127K | Phoenix Atherectomy Deflecting System, 2.4mm X127cm Kit | VOLCANO ATHEROMED, INC. | ||
15 | 00845225002701 | P22130K | Phoenix Atherectomy System, 2.2mm X 130cm Kit | VOLCANO ATHEROMED, INC. | ||
16 | 00845225002695 | P18130K | Phoenix Atherectomy System, 1.8mm X 130cm Kit | VOLCANO ATHEROMED, INC. | ||
17 | 00845225002671 | P01818 | Phoenix Wire Support Clip | VOLCANO ATHEROMED, INC. | ||
18 | 00845225002664 | P00633 | Phoenix Handle | VOLCANO ATHEROMED, INC. | ||
19 | 00845225002657 | P22149 | Phoenix Atherectomy Catheter, 2.2mm X 149cm | VOLCANO ATHEROMED, INC. | ||
20 | 00845225002640 | P18149 | Phoenix Atherectomy Catheter, 1.8mm X 149cm | VOLCANO ATHEROMED, INC. | ||
21 | 00845225002633 | PD24127 | Phoenix Atherectomy Deflecting Catheter, 2.4mm X 127cm | VOLCANO ATHEROMED, INC. | ||
22 | 00845225002626 | P22130 | Phoenix Atherectomy Catheter, 2.2mm X 130cm | VOLCANO ATHEROMED, INC. | ||
23 | 00845225002619 | P18130 | Phoenix Atherectomy Catheter, 1.8mm X 130cm | VOLCANO ATHEROMED, INC. | ||
24 | 00821684074176 | FG02550 | ATHERECTOMY FG02550 CUTTERDRIVER V04 | N/A | COVIDIEN LP | |
25 | 00821684074169 | P4056 | ATHERECTOMY P4056 SILVERHAWK ATK V03 | SilverHawkTM | COVIDIEN LP | |
26 | 00821684074145 | P4055 | ATHERECTOMY P4055 SILVERHAWK ATK V03 | SilverHawkTM | COVIDIEN LP | |
27 | 00821684074121 | P4052 | ATHERECTOMY P4052 SILVERHAWK ATK V03 | SilverHawkTM | COVIDIEN LP | |
28 | 00821684074107 | P4044 | ATHERECTOMY P4044 SILVERHAWK BTK V03 | SilverHawkTM | COVIDIEN LP | |
29 | 00821684074084 | P4034 | ATHERECTOMY P4034 SILVERHAWK BTK V03 | SilverHawkTM | COVIDIEN LP | |
30 | 00821684074060 | P4033 | ATHERECTOMY P4033 SILVERHAWK BTK V03 | SilverHawkTM | COVIDIEN LP | |
31 | 00821684074046 | P4030 | ATHERECTOMY P4030 SILVERHAWK BTK V03 | SilverHawkTM | COVIDIEN LP | |
32 | 00821684074039 | P4028 | ATHERECTOMY P4028 SILVERHAWK BTK V03 | SilverHawkTM | COVIDIEN LP | |
33 | 00821684074008 | THS-LX-C | ATHERECTOMY THS-LX-C TURBOHAWK ATK V08 | TurboHawk™ | COVIDIEN LP | |
34 | 00821684073551 | H1-14550 | ATHERECTOMY H1-14550 CUTTERDRIVER V02 | HawkOneTM | COVIDIEN LP | |
35 | 00821684065853 | THS-SX-C | ATHERECTOMY THS-SX-C TURBOHAWK BTK V03 | TurboHawk™ | COVIDIEN LP | |
36 | 00821684065839 | THS-SS-CL | ATHERECTOMY THS-SS-CL TURBOHAWK BTK V03 | TurboHawk™ | COVIDIEN LP | |
37 | 00821684065815 | THS-SS-C | ATHERECTOMY THS-SS-C TURBOHAWK BTK V03 | TurboHawk™ | COVIDIEN LP | |
38 | 00821684065785 | THS-LS-C | ATHERECTOMY THS-LS-C TURBOHAWK ATK V08 | TurboHawk™ | COVIDIEN LP | |
39 | 00821684065754 | TH-LX-M | ATHERECTOMY TH-LX-M TURBOHAWK ATK V06 | TurboHawk™ | COVIDIEN LP | |
40 | 00821684065747 | TH-LS-M | ATHERECTOMY TH-LS-M TURBOHAWK ATK V06 | TurboHawkTM | COVIDIEN LP | |
41 | 00821684057964 | H1-14550 | Cutter Driver | HawkOne | COVIDIEN LP | |
42 | 00821684057933 | H1-LX | Directional Atherectomy System, Large Vessel Extended Tip | HawkOne | COVIDIEN LP | |
43 | 00821684057926 | H1-LS | Directional Atherectomy System, Large Vessel Standard Tip | HawkOne | COVIDIEN LP | |
44 | 00821684047941 | THS-SS-CL | THS-SS-CL | Peripheral Plaque Excision System;Small Vessel Standard Tip | TurboHawk | COVIDIEN LP |
45 | 00821684047934 | THS-SS-C | THS-SS-C | Peripheral Plaque Excision System;Small Vessel Standard Tip | TurboHawk | COVIDIEN LP |
46 | 00821684047927 | THS-SX-C | THS-SX-C | Peripheral Plaque Excision System;Small Vessel Extended Tip | TurboHawk | COVIDIEN LP |
47 | 00821684047217 | THS-LS-C | THS-LS-C | Peripheral Plaque Excision System;Large Vessel Standard Tip | TurboHawk | COVIDIEN LP |
48 | 00821684047200 | THS-LX-C | THS-LX-C | Peripheral Plaque Excision System;Large Vessel Xtended Tip with MEC Technology | TurboHawk | COVIDIEN LP |
49 | 00821684047156 | TH-LS-M | TH-LS-M | Peripheral Plaque Excision System;Large Vessel Standard Tip with MEC TechNlogy | TurboHawk | COVIDIEN LP |
50 | 00821684047149 | TH-LX-M | Peripheral Plaque Excision System;Large Vessel Xtended Tip with MEC TechNlogy | TurboHawk | COVIDIEN LP |