510(k) K001901 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135
| Applicant | C.R. Bard, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Sep 19, 2000 |
| Received | Jun 22, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001901
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2026 | Bard Access Systems, Inc. CK000495A Poly Midline Catheter 4 Fr Single-Lumen
UDI-DI Code: 00801741121609
CK000566 Poly Midline Catheter 4 Fr Single-Lumen
UDI-DI Code: 00801741108051
CK000566 Poly Midline Catheter 4 Fr Single- Open, Classified |
PXI | None listed |
| Mar 13, 2015 | Bard Access Systems BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline 3F Maximal Barrier Tray (Single-L Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.