510(k) K062161 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
GORE PROPATEN VASCULAR GRAFT
| Applicant | W. L. Gore & Associates, Inc., Flagstaff AZ, US |
| Decision | Substantially Equivalent, Nov 9, 2006 |
| Received | Jul 28, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062161
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2021 | W L Gore & Associates, Inc. Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 5 mm, Length 10 cm, Rx Only, Sterile EO, for the following Reference numbers:
HPT050010 UDI: (01)00733132606320
HPT050010A UDI: Open, Classified |
DSY | None listed |
| May 12, 2021 | W L Gore & Associates, Inc. Gore Propaten Vascular Graft configured for Pediatric Shunt, Diameter 6 mm, Length 15 cm, Rx Only, Sterile EO, for the following Reference numbers:
HPT060015 UDI: (01)00733132606368
HPT060015A UDI: Open, Classified |
DSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.