QUICKSEAL SURESHOT ARTERIAL CLOSURE SYSTEM
FDA premarket approval P010049/S010 · decided 2004-05-25
Approval details
- PMA number
- P010049
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- QUICKSEAL SURESHOT ARTERIAL CLOSURE SYSTEM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Sub-Q, Inc.
- Date received
- 2003-12-02
- Decision date
- 2004-05-25
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Clemente, CA
- Statement
- APPROVAL TO MODIFY THE DESIGN OF THE QUICKSEAL ARTERIAL CLOSURE SYSTEM TO ALLOW THE DELIVERY OF Q-FOAM HEMOSTATIC SPONGE THROUGH AN INTRODUCER DELIVERY SHEATH AND ELIMINATE THE DEPTH MARKET COMPONENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME QUICKSEAL SURESHOT AND IS INDICATED FOR USE IN REDUCING TIME TO HEMOSTATIS AT FEMORAL ARTERY PUNCTURE SITES AND IN REDUCING TIME TO AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL PROCEDURES USING 8 FRENCH OR SMAL
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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 |