CLOSER S(TM) 6FR. SMC DEVICE
FDA premarket approval P960043/S026 · decided 2000-09-29
Approval details
- PMA number
- P960043
- Supplement
- S026
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CLOSER S(TM) 6FR. SMC DEVICE
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2000-08-31
- Decision date
- 2000-09-29
- Days to decision
- 29 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood, CA
- Statement
- APPROVAL FOR THE CLOSER S(TM) 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM. THE DEVICE, AS MODIFIED, IS INDICATED FOR THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC CATHETERIZATION PROCEDURES USING 5 TO 6 FR. SHEATHS. THE CLOSER S(TM) 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM REDUCES THE TIMES TO HEMOSTASIS, AMBULATION (5 METERS OR 16 FEET) AND DISCHARGE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC CATHETERIZATION PROCE
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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 |