510(k) K143480 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Euphora Rapid Exchange Balloon Dilatation Catheter
| Applicant | Medtronic, Inc., Galway, IE |
| Decision | Substantially Equivalent, Apr 2, 2015 |
| Received | Dec 8, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143480
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 3, 2019 | Medtronic Vascular Galway DBA Medtronic Ireland Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X Open, Classified |
LOX | None listed |
| Sep 20, 2017 | Medtronic Vascular Galway DBA Medtronic Ireland Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. Terminated |
LOX | None listed |
| Sep 20, 2017 | Medtronic Vascular Galway DBA Medtronic Ireland Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. Terminated |
LOX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.