510(k) K030268 ยท MPB Catheter, Hemodialysis, Non-Implanted
NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERS
| Applicant | C.R. Bard, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jul 30, 2003 |
| Received | Jan 27, 2003 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K030268
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2026 | Bard Access Systems, Inc. DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150;
DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625200;
DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625240;
DuoGlide Short Open, Classified |
MPB | None listed |
| Jul 2, 2026 | Bard Access Systems, Inc. 5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen
UDI-DI Code: 00801741042119
The intended use of the Short-Term Dialysis Catheter is attaining temporary/short-term (less than Open, Classified |
PXI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.