HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX
FDA 510(k) clearance K122612 · decided 2012-09-10
Clearance details
- K-number
- K122612
- Device name
- HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX
- Applicant
- Maquet Cardiovascular, LLC
- Decision
- Substantially Equivalent
- Date received
- 2012-08-27
- Decision date
- 2012-09-10
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- MAL
- Device class
- 2
- Regulation number
- 870.3450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Wayne, 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 |
|---|---|---|
| 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 |
| HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT (K954848) | Meadox Medicals, Div. Boston Scientific Corp. | 1996-02-01 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 7MMX100CM (P840029/S007) | Maquet Cardiovascular, LLC | 1993-05-17 |
| HEMASHIELD ETS(TM) FLANGED GRAFT (P840029/S004) | Maquet Cardiovascular, LLC | 1993-05-17 |
| HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS 12 X 6MM (P840029/S006) | Maquet Cardiovascular, LLC | 1993-05-17 |
| HEMASHIELD(R) MICROVEL (R) DOUBLE VELOUR GRAFT (P840029/S014) | Maquet Cardiovascular, LLC | 1993-05-17 |
| HEMASHIELD (R) MICROVEL (R) DOUBLE VELOUR (P840029/S011) | Maquet Cardiovascular, LLC | 1993-05-17 |
| HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS (P840029/S010) | Maquet Cardiovascular, LLC | 1993-05-11 |
| HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS (P840029/S009) | Maquet Cardiovascular, LLC | 1993-05-11 |
| HEMASHIELD WOVEN DOUBLE VELOUR GRAFTS (P840029/S005) | Maquet Cardiovascular, LLC | 1993-05-11 |