The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Euphora Rapid Exchange Balloon Dilatation Catheter.
| Device ID | K143480 |
| 510k Number | K143480 |
| Device Name: | Euphora Rapid Exchange Balloon Dilatation Catheter |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | MEDTRONIC INC. PARKMORE BUSINESS PARK WEST Galway, IE |
| Contact | John Kilmartin |
| Correspondent | Elaine Gullane MEDTRONIC INC. PARKMORE BUSINESS PARK WEST Galway, IE |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-08 |
| Decision Date | 2015-04-02 |
| Summary: | summary |