FDA Product Code
FDA Product Code MAL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3450
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K122612 | HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX | Maquet Cardiovascular, LLC | 2012-09-10 | Traditional | PDF ↗ |
| K103080 | ALBOGRAFT VASCULAR PROSTHESIS | LeMaitre Vascular, Inc. | 2011-01-19 | Traditional | PDF ↗ |
| K093231 | ALBOGRAFT VASCULAR PROSTHESIS | LeMaitre Vascular, Inc. | 2010-01-14 | Traditional | PDF ↗ |
| K052302 | HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION | Boston Scientific Corp | 2005-09-12 | Special | PDF ↗ |
| K021213 | MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS | Boston Scientific Corp | 2002-04-19 | Special | PDF ↗ |
| K954848 | HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT | Meadox Medicals, Div. Boston Scientific Corp. | 1996-02-01 | Traditional | PDF ↗ |
Product code MAL · Class II · Cardiovascular. Data: openFDA.