ALBOGRAFT VASCULAR PROSTHESIS
FDA 510(k) clearance K093231 · decided 2010-01-14
Clearance details
- K-number
- K093231
- Device name
- ALBOGRAFT VASCULAR PROSTHESIS
- Applicant
- LeMaitre Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-10-14
- Decision date
- 2010-01-14
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- MAL
- Device class
- 2
- Regulation number
- 870.3450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bedford, MA, 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 |
| 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
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Artegraft Collagen Vascular Graft (N16837/S036) | LeMaitre Vascular, Inc. | 2025-06-11 |
| Artegraft Collagen Vascular Graft (N16837/S035) | LeMaitre Vascular, Inc. | 2024-12-18 |
| Artegraft Collagen Vascular Graft (N16837/S034) | LeMaitre Vascular, Inc. | 2024-10-17 |
| Artegraft Collagen Vascular Graft (N16837/S033) | LeMaitre Vascular, Inc. | 2024-05-02 |
| Artegraft Collagen Vascular Graft (N16837/S032) | LeMaitre Vascular, Inc. | 2023-09-19 |
| Artegraft Collagen Vascular Graft (N16837/S031) | LeMaitre Vascular, Inc. | 2023-06-29 |
| Artegraft Collagen Vascular Graft (N16837/S030) | LeMaitre Vascular, Inc. | 2023-04-25 |
| Artegraft Collagen Vascular Graft (N16837/S029) | LeMaitre Vascular, Inc. | 2023-01-25 |