510(k) K040658 ยท MJC Catheter, Urological (Antimicrobial) And Accessories
BARDEX I.C. LATEX FOLEY CATHETER
| Applicant | C.R. Bard, Inc., Covington GA, US |
| Decision | Substantially Equivalent, Sep 29, 2004 |
| Received | Mar 12, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040658
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2026 | C.R. Bard Inc Products that contain the Pericare Wipes:
*Bardex I.C. Complete Care Foley Catheter Tray
REF: 300316A
UDI codes: 00801741024344 10801741024341
*Bardex I.C. Complete Care Foley Catheter Tray and Urin Open, Classified |
MJC | None listed |
| Sep 18, 2025 | C.R. Bard Inc SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A Open, Classified |
MJC | None listed |
| Sep 18, 2025 | C.R. Bard Inc SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A Open, Classified |
MJC | None listed |
| Sep 18, 2025 | C.R. Bard Inc SureStep Foley Tray System BARD Lubri-Sil Foley Catheter Tray, REF: A942216 Open, Classified |
MJC | None listed |
| Jun 18, 2024 | C.R. Bard Inc Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray with Bard Hydrogel and Bacti-Gua Open, Classified |
MJC | None listed |
| Sep 23, 2021 | C.R. Bard Inc Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device Open, Classified |
MJC | None listed |
| Sep 23, 2021 | C.R. Bard Inc Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device Open, Classified |
MJC | None listed |
| Sep 23, 2021 | C.R. Bard Inc Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device Open, Classified |
MJC | None listed |
| Apr 15, 2020 | C.R. Bard Inc SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the ur Terminated |
MJC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.