QUICKSEAL FEMORAL ARTERIAL CLOSURE SYSTEM
FDA premarket approval P010049 · decided 2002-03-25
Approval details
- PMA number
- P010049
- Trade name
- QUICKSEAL FEMORAL ARTERIAL CLOSURE SYSTEM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Sub-Q, Inc.
- Date received
- 2001-09-10
- Decision date
- 2002-03-25
- Days to decision
- 196 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Clemente, CA
- Statement
- APPROVAL FOR THE QUICKSEAL FEMORAL ARTERIAL CLOSURE SYSTEM. THE DEVICE IS INDICATED FOR THE DELIVERY OF GELFOAM FOR THE EXTRAVASCULAR CLOSURE OF THE FEMORAL ARTERY ACCESS SITE. THE SYSTEM IS INDICATED FOR USE IN REDUCING TIME TO HEMOSTASIS AT FEMORAL ARTERY PUNCTURE SITES AND IN REDUCING TIME TO AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL PROCEDURES USING 8 FRENCH OR SMALLER PROCEDURAL SHEATHS. THE DEVICE REDUCES TIME TO ELIGIBILITY FOR HOSPITAL DISCHARGE IN PATIENTS W
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| QS DELIVERY SYSTEM (K991254) | Sub-Q, Inc. | 1999-08-23 |
| IRRIGATION SYRINGE KIT (K982435) | Sub-Q, Inc. | 1998-11-06 |