510(k) K964625 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES
| Applicant | Intervascular, Inc., Clearwater FL, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., May 5, 1997 |
| Received | Nov 15, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964625
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 28, 2010 | Intervascular S.A.S. InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625;
InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294. Terminated |
DSY | None listed |
| Apr 23, 2010 | Intervascular S.A.S. InterGard Knitted Collagen Coated Vascular prostheses, Catalog number: IGK1206. InterVascular SAS, France.
Indicated for surgical repair, bypass or replacement of arteries in the treatment of aneur Terminated |
DSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.