QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM
FDA premarket approval P010049/S003 · decided 2002-11-27
Approval details
- PMA number
- P010049
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Sub-Q, Inc.
- Date received
- 2002-11-15
- Decision date
- 2002-11-27
- Days to decision
- 12 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Clemente, CA
- Statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY TO PERFORM DEVICE ASSEMBLY AND PACKAGING, LOCATED AT SUB-Q, INC., SAN CLEMENTE, CALIFORNIA.
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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 |