HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH
FDA 510(k) clearance K962342 · decided 1996-09-10
Clearance details
- K-number
- K962342
- Device name
- HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH
- Applicant
- Meadox Medicals, Div. Boston Scientific Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-06-18
- Decision date
- 1996-09-10
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- DXZ
- Device class
- 2
- Regulation number
- 870.3470
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Oakland, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hemashield Finesse Ultra-Thin Knitted Cardiovascular Patch Indicated for cardiac and vascu recall (Z-1593-2011) | Maquet Cardiovascular, LLC | 2011-03-07 |
| Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch. recall (Z-2064-2010) | Maquet Cardiovascular, LLC | 2010-07-22 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| STRKYER KNEE AUGMENTATION GRAFT (P850054) | Meadox Medicals, Div. Boston Scientific Corp. | 1988-12-30 |