510(k) K050276 ยท QEZ Aspiration Thrombectomy Catheter
DIVER C.E. CATHETER
| Applicant | Invatec Innovative Technologies, S.R.L., Plymouth MN, US |
| Decision | Substantially Equivalent, Mar 7, 2005 |
| Received | Feb 7, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050276
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 7, 2013 | Invatec Llc lnvatec SpA brand Diver C.E., Model/Catalog Numbers: DVR010014145, DVR011014145,
Product is manufactured by lnvatec SpA, Roncadelle, Italy, and distributed by Invatec, Inc., Bethlehem, PA and by Me Terminated |
DXE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.