HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT
FDA 510(k) clearance K954848 · decided 1996-02-01
Clearance details
- K-number
- K954848
- Device name
- HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT
- Applicant
- Meadox Medicals, Div. Boston Scientific Corp.
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 1995-10-23
- Decision date
- 1996-02-01
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- MAL
- Device class
- 2
- Regulation number
- 870.3450
- 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
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX (K122612) | Maquet Cardiovascular, LLC | 2012-09-10 |
| ALBOGRAFT VASCULAR PROSTHESIS (K103080) | LeMaitre Vascular, Inc. | 2011-01-19 |
| ALBOGRAFT VASCULAR PROSTHESIS (K093231) | LeMaitre Vascular, Inc. | 2010-01-14 |
| HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION (K052302) | Boston Scientific Corp | 2005-09-12 |
| MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS (K021213) | Boston Scientific Corp | 2002-04-19 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hemashield Gold Woven and Knitted Double Vascular Grafts. recall (Z-2066-2010) | 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 |