QUICKSEAL CONTROL ARTERIAL CLOSURE SYSTEM
FDA premarket approval P010049/S008 · decided 2003-08-13
Approval details
- PMA number
- P010049
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- QUICKSEAL CONTROL ARTERIAL CLOSURE SYSTEM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Sub-Q, Inc.
- Date received
- 2003-06-30
- Decision date
- 2003-08-13
- Days to decision
- 44 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Clemente, CA
- Statement
- APPROVAL TO MODIFY THE DEVICE TO REDUCE THE NUMBER OF PREPARATION STEPS, SIMPLIFY THE METHOD OF STAGING THE HEMOSTATIC SPONGE INTO DELIVERY CANNULA AND PROVIDE AN EASIER INTERFACE FOR FLUSHING THE DEPTH MARKER.
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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 |