510(k) K133856 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
POWERGLIDE MIDLINE CATHETER
| Applicant | C.R. Bard, Inc., Salt Lake Ciy, UT, US |
| Decision | Substantially Equivalent, Jan 16, 2014 |
| Received | Dec 19, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K133856
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2015 | Bard Access Systems BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerGlide Midline Catheter Full Kit (20G) (8cm), PowerGlide Midline Catheter Maximal Barrier Tray (20G) (8cm), PowerGlid Terminated |
FOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.