510(k) K983819 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN
| Applicant | Intervascular, Inc., Clearwater FL, US |
| Decision | Substantially Equivalent, Nov 24, 1998 |
| Received | Oct 29, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K983819
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Datascope Corporation HemaCarotid Patch, Ultrathin, Collagen Coated Knitted Polyester Vascular Patch.
Product Catalog Numbers:
HEK06/75CPUT;
HEK08/75CPUT;
HEK14/75CPUT;
HEK08/120CPUT;
HEK10/75CPUT;
HEK25/100CPUT;
HEK12/ Terminated |
DSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.