Data / Medical devices / Graft, Vascular, Synthetic/Biologic Composite
Graft, Vascular, Synthetic/Biologic Composite (MAL): 4 FDA-registered makers in 3 countries
4 establishments in 3 countries are registered with the FDA to make Graft, Vascular, Synthetic/Biologic Composite (product code MAL, Class 2, 21 CFR 870.3450). 4 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on September 10, 2012, and lists 7 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- MAL
- Device class
- 2
- Regulation
- 870.3450
- Medical specialty
- Cardiovascular
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| France | 1 |
| United Kingdom | 1 |
Makers of Graft, Vascular, Synthetic/Biologic Composite
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Intervascular SAS | LA CIOTAT Bouches-du-Rhone, France | Manufacturer | 3 | September 12, 2005 | 0 | 0 | 0 | api.fda.gov |
| Lemaitre Vascular, Inc. | Burlington, MA, United States | Manufacturer | 1 | January 14, 2010 | 0 | 1 | 1 | api.fda.gov |
| LeMaitre Vascular Inc. | Billerica, MA, United States | Manufacturer | 1 | January 14, 2010 | 0 | 0 | 0 | api.fda.gov |
| Vascutek Ltd. | Inchinnan Renfrewshire, United Kingdom | Manufacturer | 0 | 1 | 1 | 0 | api.fda.gov |
Updated September 10, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.