CLOSER PERCUTANEOUS VASCULAR SURGERY DEVICE
FDA premarket approval P960043/S019 · decided 1999-11-22
Approval details
- PMA number
- P960043
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CLOSER PERCUTANEOUS VASCULAR SURGERY DEVICE
- Applicant
- Abbott Vascular, Inc.
- Date received
- 1999-05-03
- Decision date
- 1999-11-22
- Days to decision
- 203 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood, CA
- Statement
- Approval for the Closer(TM) PVS Device and the following accessories: the Perclose Mini Knot Pusher, Perclose Snared Knot Pusher and the Clincher(TM) Knot Tying Device. The device is indicated for the percutaneous delivery of suture for closing hte common femoral artery access sie of patients who have undergone diagnostic catheterization procedures using 5 to 6 Fr. sheaths. The Closer(TM) 6 Fr. PVS System reduces the times to hemostasis, ambulation (5 meters or 16 feet) and discharge in patients
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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 |