BIOPATCH BOVINE PERICARDIAL PATCH
FDA 510(k) clearance K840756 · decided 1985-02-08
Clearance details
- K-number
- K840756
- Device name
- BIOPATCH BOVINE PERICARDIAL PATCH
- Applicant
- Meadox Medicals, Div. Boston Scientific Corp.
- Decision
- Substantially Equivalent
- Date received
- 1984-02-23
- Decision date
- 1985-02-08
- Days to decision
- 351 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Oakland, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| STRKYER KNEE AUGMENTATION GRAFT (P850054) | Meadox Medicals, Div. Boston Scientific Corp. | 1988-12-30 |