510(k) K053345 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D
| Applicant | Medcomp, Harleysville PA, US |
| Decision | Substantially Equivalent, Mar 17, 2006 |
| Received | Dec 2, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053345
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2008 | Medical Components, Inc dba MedComp USCT5D, Pro-PICC CT 5F x 55 cm Dual Lumen. infusion catheter insertion kit. The product is shipped 5 units per box and is indicated for short and long term access to the central venous system. Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.