510(k) K070582 ยท EZL Catheter, Retention Type, Balloon
BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS
| Applicant | C.R. Bard, Inc., Covington GA, US |
| Decision | Substantially Equivalent, Dec 7, 2007 |
| Received | Mar 1, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070582
| 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 |
| Aug 28, 2025 | C.R. Bard Inc Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314;
SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514 Open, Classified |
EZL | None listed |
| Sep 23, 2021 | C.R. Bard Inc Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device Open, Classified |
MJC | None listed |
| Sep 23, 2021 | C.R. Bard Inc Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device Open, Classified |
MJC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.