510(k) K101928 ยท FTL Mesh, Surgical, Polymeric
VENTRALEX ST HERNIA PATCH
| Applicant | C.R. Bard, Inc., Warwick RI, US |
| Decision | Substantially Equivalent, Mar 23, 2011 |
| Received | Jul 9, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101928
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2011 | Davol, Inc., Sub. C. R. Bard, Inc. Bard Ventralex" ST Medium Circle with Strap Hernia Patch Diameter 6.4cm /2.5", Catalog Number: 5950008.
Intended for use in the reconstruction of soft tissue, where weakness exists, in procedures inv Terminated |
FTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.