510(k) K060163 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
CARDIOFLON, CARDIOXYL
| Applicant | Peters Surgical, Bobigny, FR |
| Decision | Substantially Equivalent, Oct 11, 2006 |
| Received | Jan 23, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K060163
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2014 | Peters Surgical The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with p Terminated |
GAT | None listed |
| Sep 22, 2014 | Peters Surgical The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene terephtalate)] braids, coated, with or without PLEDGETS of different sizes.
CARDIOFLON Evolu Terminated |
GAT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.