510(k) K081777 ยท FTL Mesh, Surgical, Polymeric
VENTRIO HERNIA PATCH
| Applicant | C.R. Bard, Inc., Warwick RI, US |
| Decision | Substantially Equivalent, Sep 29, 2008 |
| Received | Jun 23, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081777
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2010 | Davol, Inc., Sub. C. R. Bard, Inc. BARD Ventrio Small Oval Hernia Patch 3.1" x 4.7"
Product Code: 0010211
Indicated for use in the reconstruction of soft tissue deficiencies such as for the repair of hernias. Terminated |
FTL | None listed |
| Nov 19, 2010 | Davol, Inc., Sub. C. R. Bard, Inc. BARD Ventrio Large Oval Hernia Patch 5.4" x 7.0"
Product Code: 0010212
Indicated for use in the reconstruction of soft tissue deficiencies such as for the repair of hernias. Terminated |
FTL | None listed |
| Nov 19, 2010 | Davol, Inc., Sub. C. R. Bard, Inc. BARD Ventrio Small Circle Hernia Patch 3.0"
Product Code: 0010213
Indicated for use in the reconstruction of soft tissue deficiencies such as for the repair of hernias. Terminated |
FTL | None listed |
| May 4, 2010 | Davol, Inc., Sub. C. R. Bard, Inc. Bard Ventrio Small Oval Hernia Patch 8cm X 12cm (3.1" x 4.7"), Warwick, RI
Product Code: 0010211
The Ventrio Hernia Patch is a self-expanding non-absorbable, sterile prosthesis, containing two prima Terminated |
FTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.