VASCUTEK GELSEAL(TM) VASCULAR GRAFT
FDA premarket approval P890045/S006 · decided 1994-07-22
Approval details
- PMA number
- P890045
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VASCUTEK GELSEAL(TM) VASCULAR GRAFT
- Generic name
- GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
- Applicant
- Carbomedics, Inc.
- Date received
- 1994-04-18
- Decision date
- 1994-07-22
- Days to decision
- 95 days
- Decision code
- APPR
- Product code
- MAL
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Austin, TX
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ANNULOFLO SYSTEM (K970375) | Carbomedics, Inc. | 1997-07-25 |
| VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) (K964665) | Carbomedics, Inc. | 1997-02-19 |
| CARBOMEDICS HANDLE (K962154) | Carbomedics, Inc. | 1996-08-27 |
| CARBOMEDICS MITRAL ROTATOR (K960923) | Carbomedics, Inc. | 1996-04-29 |
| VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT (K960706) | Carbomedics, Inc. | 1996-04-25 |
| CARBOMEDICS VALVE TESTER (K960169) | Carbomedics, Inc. | 1996-04-15 |
| VASCUTEK GRAFT SIZER SET (K955588) | Carbomedics, Inc. | 1996-03-07 |
| CARBOMEDICS SUPRA-ANNULAR VALVE SIZER (K952184) | Carbomedics, Inc. | 1995-11-29 |