510(k) K980992 ยท FPA Set, Administration, Intravascular
IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES
| Applicant | Venetec Intl., Inc., Irvine CA, US |
| Decision | Substantially Equivalent, May 28, 1998 |
| Received | Mar 17, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980992
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 29, 2009 | C.R. Bard, Inc., Urological Division Bard StatLock Intravenous (IV) Catheter Stabilization Kit, Catalog number: IVK0124, C.R. Bard, Inc., Covington, GA 30014, USA. Terminated |
FPA | None listed |
| Jun 12, 2003 | Venetec Intl Inc StatLock Tandem Microbore Catheter Extension Set with preattached Clearlink Valve 6'' LL. Model number 2N9205K. Terminated |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.