510(k) K910318 ยท MJC Catheter, Urological (Antimicrobial) And Accessories
BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER
| Applicant | C.R. Bard, Inc., Covington GA, US |
| Decision | Substantially Equivalent, Aug 18, 1994 |
| Received | Jan 24, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910318
| 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 23, 2021 | C.R. Bard Inc Catalog A300314A, 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 A300318A, 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 A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device Open, Classified |
MJC | None listed |
| Feb 6, 2019 | Bard Medical Division SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray, Product Codes: A119214M, A119216M, A119218M, A119416M, A153200, A300916A, A301216, A301216A, A303314A, A303316A, A303318A, A3034 Terminated |
MJC | None listed |
| Dec 6, 2018 | Bard Medical Division BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile.
Intended for use Open, Classified |
MJC | None listed |
| Dec 18, 2015 | C.R. Bard, Inc. BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical Terminated |
MJC | None listed |
| Dec 18, 2015 | C.R. Bard, Inc. BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model); Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, void Terminated |
MJC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.