510(k) K984136 ยท MJC Catheter, Urological (Antimicrobial) And Accessories
BARDEX LUBRI-SIL I.C. FOLEY CATHETER
| Applicant | Bard Medical Div., Covington GA, US |
| Decision | Substantially Equivalent, Feb 16, 1999 |
| Received | Nov 18, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984136
| 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 |
| Aug 21, 2003 | C.R. Bard, Inc., Urological Division Bardex Foley Catheter, 22 Fr 40cc- 20cc Ribbed Balloons, Coleman Model Red Latex, 3 Way Radiopaque, Lubricath Coated, Sterile, Single Use Device, C.R. Bard, Inc., Covington, GA 30014. The catheter is Terminated |
MJC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.