Euphora Rapid Exchange Balloon Dilatation Catheter
FDA 510(k) clearance K143480 · decided 2015-04-02
Clearance details
- K-number
- K143480
- Device name
- Euphora Rapid Exchange Balloon Dilatation Catheter
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-12-08
- Decision date
- 2015-04-02
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- LOX
- Device class
- 2
- Regulation number
- 870.5100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Galway, IE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary A recall (Z-3136-2017) | Medtronic Vascular Galway DBA Medtronic Ireland | 2017-09-20 |
| Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary recall (Z-3137-2017) | Medtronic Vascular Galway DBA Medtronic Ireland | 2017-09-20 |
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|---|---|---|
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