PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM
FDA premarket approval P960043 · decided 1997-04-30
Approval details
- PMA number
- P960043
- Trade name
- PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Abbott Vascular, Inc.
- Date received
- 1996-11-26
- Decision date
- 1997-04-30
- Days to decision
- 155 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- Yes
- Location
- Redwood, CA
- Statement
- APPROVAL FOR THE PROSTAR(R) PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM. THE PROSTAR(R) PVS SYSTEM CONSISTS OF THE PROSTAR(R) PVS DEVICE (9 AND 11 FRENCH SIZES) AND THE FOLLOWING ACCESSORIES: A PROSTAR(R) PRE-DILATOR (9 AND 11 FRENCH SIZES), A PERCLOSE(R) KNOT PUSHER, AND PROSTAR(R) TRANSITION GUIDEWIRE, AND A PERCLOSE(R) ARTERIAL TAMPER. THE PROSTAR(R) PVS SYSTEM IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURES FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE ANC REDUCING THE TIME TO HEMO
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Hi-Torque JET Guide Wire Family (K142415) | Abbott Vascular, Inc. | 2014-12-19 |
| PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY (K123067) | Abbott Vascular, Inc. | 2013-01-29 |
| HI-TORQUE COMMAND GUIDE WIRE FAMILY (K122573) | Abbott Vascular, Inc. | 2012-11-20 |
| ARMADA 14 PTA CATHETER (K102705) | Abbott Vascular, Inc. | 2010-12-07 |
| HI-TORQUE WINN GUIDE WIRE FAMILY (K101648) | Abbott Vascular, Inc. | 2010-07-08 |
| HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL (K101011) | Abbott Vascular, Inc. | 2010-05-24 |
| HI-TORQUE PROGRESS GUIDE WIRE FAMILY (K091825) | Abbott Vascular, Inc. | 2009-09-25 |
| FOXCROSS PTA CATHETER (K081417) | Abbott Vascular, Inc. | 2008-06-04 |