510(k) K990503 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS
| Applicant | Sulzermedica, Austin TX, US |
| Decision | Substantially Equivalent, Dec 9, 1999 |
| Received | Feb 17, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990503
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2013 | Terumo Cardiovascular Systems Corporation Vascutek Gelsoft Vascular Graft (peripheral)
Labeling reads in part, "***Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis***STRAIGHT***STERILE***EO***Item No: 631508***Diameter 8mm***Usable Len Terminated |
DSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.