VALVE SIZER
FDA 510(k) clearance K934951 · decided 1993-12-10
Clearance details
- K-number
- K934951
- Device name
- VALVE SIZER
- Applicant
- Carbomedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-10-18
- Decision date
- 1993-12-10
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- DTI
- Device class
- 1
- Regulation number
- 870.3945
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CARBOMEDICS SUPRA-ANNULAR VALVE SIZER (K952184) | Carbomedics, Inc. | 1995-11-29 |
| EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET (K881279) | Baxter Healthcare Corp | 1988-05-18 |
| DUROMEDICS CARDIAC VALVE SIZER SET (K853313) | Hemex Scientific, Inc. | 1985-11-01 |
| METRONIC MODEL F7700 HEART VALVE SIZERS (K852612) | Medtronic Vascular | 1985-09-23 |
| MITRAL VALVE ORIFICE SIZER (K820887) | Celtech | 1982-07-08 |
| HANCOCK * OBTURATORS (K801885) | Hancock Laboratories, Inc. | 1980-09-09 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VASCUTEK GELSOFT(TM) VASCULAR GRAFT (P890045/S001) | Carbomedics, Inc. | 1995-07-05 |
| VASCUTEK GELSEAL(TM) VASCULAR GRAFT (P890045/S005) | Carbomedics, Inc. | 1995-04-13 |
| VASCUTEK GELSEAL(TM) VASCULAR GRAFT (P890045/S006) | Carbomedics, Inc. | 1994-07-22 |
| VASCUTEK GELSOFT(TM) VASCULAR GRAFT (P890045/S003) | Carbomedics, Inc. | 1993-12-07 |
| GELSEAL TM TRIAXIAL VASCULAR GRAFT (P890045) | Carbomedics, Inc. | 1993-01-11 |