510(k) K821745 ยท KOD Catheter, Urological
BARDEX ALL SILICONE PEDIATRIC CATHETER
| Applicant | C.R. Bard, Inc., Warrendale PA, US |
| Decision | Substantially Equivalent, Jun 24, 1982 |
| Received | Jun 14, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821745
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2012 | C.R. Bard, Inc., Urological Division 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used Terminated |
KOD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.