510(k) K901185 ยท FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
FOLEY CATHETER INSERTION TRAY (10CC)
| Applicant | Orion Life Systems, Inc., Wheeling IL, US |
| Decision | Unknown, Jul 20, 1990 |
| Received | Mar 13, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901185
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2014 | Teleflex Medical RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730. Terminated |
FCM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.