510(k) K103551 ยท FPA Set, Administration, Intravascular
INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS,
| Applicant | Baxter Healthcare Corp, Mcgaw Park IL, US |
| Decision | Substantially Equivalent, Mar 25, 2011 |
| Received | Dec 2, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103551
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2013 | Baxter Healthcare Corp. A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7", Vol. 1.10 mL, Luer Activated Valve for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabiliza Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.