510(k) K033814 ยท FTL Mesh, Surgical, Polymeric
BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007
| Applicant | C.R. Bard, Inc., Cranston RI, US |
| Decision | Substantially Equivalent, Mar 1, 2004 |
| Received | Dec 9, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033814
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2011 | Davol, Inc., Sub. C. R. Bard, Inc. Bard Soft Mesh 4"x6" (10cm x 15cm) Flat, Product Code: 0117010.
The Bard Soft Mesh patch is a non-absorbable, sterile prosthesis. It has a large pore design and is constructed of knitted polypropy Terminated |
FTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.