510(k) K162443 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
PowerPICC Provena Catheters
| Applicant | C.R. Bard, Inc., Salt Lake Ciy, UT, US |
| Decision | Substantially Equivalent, Oct 25, 2016 |
| Received | Aug 31, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K162443
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2018 | Bard Access Systems Inc. PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen. Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration. Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.