MAL · Graft, Vascular, Synthetic/Biologic Composite
Cardiovascular · 21 CFR 870.3450 · Class 2
Overview
| Product Code | MAL |
|---|---|
| Device Name | Graft, Vascular, Synthetic/Biologic Composite |
| Regulation | 21 CFR 870.3450 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Implant | Yes |
Identification
A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.
Classification Rationale
Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K122612 | HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX | Maquet Cardiovascular, LLC | Sep 10, 2012 | SESE |
| K103080 | ALBOGRAFT VASCULAR PROSTHESIS | LeMaitre Vascular, Inc. | Jan 19, 2011 | SESE |
| K093231 | ALBOGRAFT VASCULAR PROSTHESIS | LeMaitre Vascular, Inc. | Jan 14, 2010 | SESE |
| K052302 | HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION | Boston Scientific Corp | Sep 12, 2005 | SESE |
| K021213 | MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS | Boston Scientific Corp | Apr 19, 2002 | SESE |
| K954848 | HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT | Meadox Medicals, Div. Boston Scientific Corp. | Feb 1, 1996 | ST |
| P920027 | ALBUMIN COATED DEBAKEY(R) VASCULAR(R) VASCULAR-II | C.R. Bard, Inc. | Oct 21, 1994 | APRL |
| P890045 | GELSEAL TM TRIAXIAL VASCULAR GRAFT | Carbomedics, Inc. | Jan 11, 1993 | APRL |
Top Applicants
- LeMaitre Vascular, Inc. — 2 clearances
- Boston Scientific Corp — 2 clearances
- Meadox Medicals, Div. Boston Scientific Corp. — 1 clearance
- Maquet Cardiovascular, LLC — 1 clearance
- Carbomedics, Inc. — 1 clearance
