510(k) K210264 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
BD PowerPiCC Catheter
| Applicant | Bard Access Systems, Inc., Salt Lake Ciy, UT, US |
| Decision | Substantially Equivalent, Jul 30, 2021 |
| Received | Feb 1, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210264
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2026 | Bard Access Systems, Inc. 1174108 PowerPICC Catheter 4 Fr Single-Lumen
UDI-DI Code: 00801741154935
1295108 PowerPICC SOLO Catheter 5 Fr Dual-Lumen
UDI-DI Code: 00801741034602
1174108D3 PowerPICC Catheter 4 Fr Single-Lumen
UD Open, Classified |
LJS | None listed |
| Apr 16, 2025 | Bard Access Systems, Inc. BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 217 Open, Classified |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.