510(k) K040504 ยท EZL Catheter, Retention Type, Balloon
BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS
| Applicant | C.R. Bard, Inc., Covington GA, US |
| Decision | Substantially Equivalent, May 14, 2004 |
| Received | Feb 27, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040504
| 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 |
| Sep 23, 2021 | C.R. Bard Inc Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device Open, Classified |
EZL | None listed |
| Sep 23, 2021 | C.R. Bard Inc Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabilization Device Open, Classified |
EZL | None listed |
| Sep 23, 2021 | C.R. Bard Inc Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device Open, Classified |
EZL | None listed |
| Sep 23, 2021 | C.R. Bard Inc Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" Stabilization Device Open, Classified |
EZL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.