MAL
6 FDA 510(k) clearances · Product code
92 daysmedian time to decision
101 days90th percentile
6clearances measured
FDA profile
- Official device name
- Graft, Vascular, Synthetic/Biologic Composite
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3450
- Medical specialty
- Cardiovascular
- Flags
- Implant
- Adverse events (MAUDE)
- 2019: 28 · 2020: 24 · 2021: 34 · 2022: 21 · 2023: 16 · 2025: 28
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| 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 |
| HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT (K954848) | Meadox Medicals, Div. Boston Scientific Corp. | 1996-02-01 |
Track MAL automatically
Every clearance here is in the API, with alerts when new ones post.