BDH UNIPOLAR FEMORAL COMPONENT A2
FDA 510(k) clearance K833403 · decided 1984-01-10
Clearance details
- K-number
- K833403
- Device name
- BDH UNIPOLAR FEMORAL COMPONENT A2
- Applicant
- Carbomedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-09-30
- Decision date
- 1984-01-10
- Days to decision
- 102 days
- Clearance type
- Traditional
- Product code
- KWL
- Device class
- 2
- Regulation number
- 888.3360
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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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 |