Graft, Vascular, Synthetic/Biologic Composite
The synthetic/biologic composite vascular graft is a cardiovascular implant used to replace or bypass diseased blood vessels, combining synthetic polymer materials with biological components to improve biocompatibility and patency. It is classified as FDA Class II under 21 CFR 870.3450, requiring 510(k) premarket clearance within the Cardiovascular specialty. The product code is MAL and the implant flag is set, reflecting its permanent or long-term surgical placement within the vascular system. Full GMP quality system requirements apply.
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Basic Information
- Product Code
- MAL
- Device Class
- FDA class 2
- Regulation Number
- 870.3450
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K122612 | HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXXXX | Sep 10, 2012 | Substantially Equivalent | Maquet Cardiovascular, LLC |
| K103080 | ALBOGRAFT VASCULAR PROSTHESIS | Jan 19, 2011 | Substantially Equivalent | LeMaitre Vascular, Inc. |
| K093231 | ALBOGRAFT VASCULAR PROSTHESIS | Jan 14, 2010 | Substantially Equivalent | LeMaitre Vascular, Inc. |
| K052302 | HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION | Sep 12, 2005 | Substantially Equivalent | Boston Scientific Corp |
| K021213 | MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS | Apr 19, 2002 | Substantially Equivalent | Boston Scientific Corp |
| K954848 | HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT | Feb 01, 1996 | Substantially Equivalent - Subject to Tracking Reg. | Meadox Medicals, Div. Boston Scientific Corp. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.