510(k) K213203 ยท PND Midline Catheter
Provena(TM) Midline Catheter
| Applicant | C.R. Bard, Inc., Salt Lake Ciy, UT, US |
| Decision | Substantially Equivalent, May 13, 2022 |
| Received | Sep 29, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K213203
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2026 | Bard Access Systems, Inc. CK000880 Provena Midline Catheter 4 Fr Dual-Lumen
UDI-DI Code: 00801741188770
S4153108BDP Provena Midline Catheter 3 Fr Single-Lumen
UDI-DI Code: 00801741154003
S4153108BP Provena Midline Catheter 3 Open, Classified |
PND | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.