510(k) K910197 ยท EZC Catheter, Coude
HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS
| Applicant | C.R. Bard, Inc., Covington GA, US |
| Decision | Substantially Equivalent, Aug 9, 1991 |
| Received | Jan 16, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910197
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2026 | C.R. Bard Inc Products that contain the Pericare Wipes:
Bardex Lubricath Foley Catheter Tray
REF:
899914
899916
899918
UDI codes:
00801741024801 10801741024808
00801741024818 10801741024815
00801741024825 10801741 Open, Classified |
EZC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.