510(k) K153393 ยท PND Midline Catheter
PowerMidline Catheter
| Applicant | C.R. Bard, Inc., Salt Lake Ciy, UT, US |
| Decision | Substantially Equivalent, Jun 28, 2016 |
| Received | Nov 24, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153393
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2026 | Bard Access Systems, Inc. CK000727 PowerMidline Catheter 4 Fr Single-Lumen
UDI-DI Code: 00801741138478
CK000729 PowerMidline Catheter 4 Fr Single-Lumen
UDI-DI Code: 00801741138713
P4153108D PowerMidline Catheter 3 Fr Single- Open, Classified |
PND | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.