VERSAFLEX; BUCHBINDER, OMNIFLEX PTCA CATHETER SYSTEMS MEDTRONIC 18K, 14K, EVERGREEN, FALCON, PANTHER, AND SPIRIT PTCAR
FDA premarket approval P870036/S036 · decided 1996-04-08
Approval details
- PMA number
- P870036
- Supplement
- S036
- Supplement type
- Normal 180 Day Track
- Trade name
- VERSAFLEX; BUCHBINDER, OMNIFLEX PTCA CATHETER SYSTEMS MEDTRONIC 18K, 14K, EVERGREEN, FALCON, PANTHER, AND SPIRIT PTCAR
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Medtronics Interventional Vascular
- Date received
- 1995-07-17
- Decision date
- 1996-04-08
- Days to decision
- 266 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- REVISED LABELING
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MEDTRONIC 5F & 9F ZUMA GUIDING CATHETERS (K990707) | Medtronics Interventional Vascular | 1999-03-22 |
| MEDTRONIC ANGIOGRAPHIC CATHETER (K980973) | Medtronics Interventional Vascular | 1998-12-10 |
| MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER (K982883) | Medtronics Interventional Vascular | 1998-09-04 |
| MEDTRONIC ZUMA GUIDING CATHETER (K981198) | Medtronics Interventional Vascular | 1998-08-07 |
| MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT (K972944) | Medtronics Interventional Vascular | 1997-11-03 |
| MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX) (K961917) | Medtronics Interventional Vascular | 1996-11-20 |
| MEDTRONIC EVERST 30 INFLATION DEVICE/SURVIVAL KIT (K960983) | Medtronics Interventional Vascular | 1996-05-30 |
| MEDTRONIC SHERPA GUIDING CATHETER (K955651) | Medtronics Interventional Vascular | 1996-01-22 |