MAL — Graft, Vascular, Synthetic/Biologic Composite Class II
FDA Device Classification
Classification Details
- Product Code
- MAL
- Device Class
- Class II
- Regulation Number
- 870.3450
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K122612 | maquet cardiovascular | HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXX | September 10, 2012 |
| K103080 | lemaitre vascular | ALBOGRAFT VASCULAR PROSTHESIS | January 19, 2011 |
| K093231 | lemaitre vascular | ALBOGRAFT VASCULAR PROSTHESIS | January 14, 2010 |
| K052302 | boston scientific | HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION | September 12, 2005 |
| K021213 | boston scientific | MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS | April 19, 2002 |
| K954848 | meadox medicals, div. boston scientific | HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT | February 1, 1996 |