510(k) K033389 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
POWERPICC CATHETERS, MODELS 3175155, 3175135
| Applicant | C.R. Bard, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Mar 19, 2004 |
| Received | Oct 23, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033389
| 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: Bard Poly Midline 3F Full Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline 3F Maximal Barrier Tray (Single-L Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.