510(k) K892855 ยท KOE Dilator, Urethral
URETHRAL BALLOON DILATION CATHETER SET
| Applicant | Cook Urological, Inc., Spencer IN, US |
| Decision | Substantially Equivalent, Nov 17, 1989 |
| Received | Apr 18, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K892855
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2019 | Cook Inc. Urethral Dilation Balloon Catheter with Open Tip
, Global Product No. G17844 Terminated |
KOE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.