510(k) K081272 ยท FTM Mesh, Surgical
PORCINE SURGICAL MESH; DERMAL MATRIX
| Applicant | Brennen Medical, LLC, St. Paul MN, US |
| Decision | Substantially Equivalent, Jul 31, 2008 |
| Received | May 5, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081272
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 2, 2011 | Davol, Inc., Sub. C. R. Bard, Inc. XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix
10 x 15 cm Rectangle
Catalog #: 1161015 Terminated |
FTM | None listed |
| Mar 2, 2011 | Davol, Inc., Sub. C. R. Bard, Inc. XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix
15 x 20 cm Rectangle
Catalog #: 1161520 Terminated |
FTM | None listed |
| Mar 2, 2011 | Davol, Inc., Sub. C. R. Bard, Inc. XenMatrix Surgical Graft Sterile, Porcine Dermal Matrix
19 x 28 cm Rectangle
Catalog #: 1161928 Terminated |
FTM | None listed |
| Mar 2, 2011 | Davol, Inc., Sub. C. R. Bard, Inc. XenMatrix Surgical Graft ,Sterile, Porcine Dermal Matrix
19 x 35 cm Rectangle
Catalog #: 1161935 Terminated |
FTM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.