510(k) K081904 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY)
| Applicant | Medcomp, Harleysville PA, US |
| Decision | Substantially Equivalent, Sep 23, 2008 |
| Received | Jul 3, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081904
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 11, 2013 | Vygon Corporation Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter. Terminated |
LJS | None listed |
| Feb 28, 2013 | Medical Components, Inc dba MedComp REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components
Product Usage: Power injectable infusion PICC insertion kits Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.