510(k) K083919 ยท DQY Catheter, Percutaneous
AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
| Applicant | Invatec Innovative Technologies, S.R.L., Bethlehem PA, US |
| Decision | Substantially Equivalent, Mar 13, 2009 |
| Received | Dec 31, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083919
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2015 | Medtronic Vascular, Inc. Amphirion Deep OTW PTA Balloon Catheter:
Model numbers:
US: AMP015020152 AMP020150152 AMP025120152 AMP030080152 AMP040040152 AMP225210152 AMP020040152 AMP025040152 AMP025150152 AMP030120152 AMP040080 Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.