510(k) K070508 ยท EZL Catheter, Retention Type, Balloon
BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR
| Applicant | C.R. Bard, Inc., Covington GA, US |
| Decision | Substantially Equivalent, Mar 9, 2007 |
| Received | Feb 22, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070508
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2026 | C.R. Bard Inc Products that contain the Pericare Wipes:
Bard Foley Tray With Lubri-Sil All-Silicone Foley Catheter
REF:
947314
947316
947318
UDI codes:
00801741024924 10801741024921
00801741024931 10801741024938
0 Open, Classified |
EZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.