510(k) K162900 ยท PND Midline Catheter
PowerMidline Catheter
| Applicant | C.R. Bard, Inc., Salt Lake Ciy, UT, US |
| Decision | Substantially Equivalent, Dec 14, 2016 |
| Received | Oct 17, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162900
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2026 | Bard Access Systems, Inc. CK000980A PowerMidline Catheter 4 Fr Dual-Lumen
UDI-DI Code: 00801741236150
P4254108 PowerMidline Catheter 4 Fr Dual-Lumen
UDI-DI Code: 00801741129278
P4254108D PowerMidline Catheter 4 Fr Dual-Lumen Open, Classified |
PND | None listed |
| Sep 14, 2020 | Becton Dickinson & Company Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media
Ref: P615 Terminated |
PND | None listed |
| Sep 14, 2020 | Becton Dickinson & Company Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media
Ref: P6153 Terminated |
PND | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.