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FDA 510(k), K143480, Euphora Rapid Exchange Balloon Dilatation Catheter
FDA 510(k), K143480, Euphora Rapid Exchange Balloon Dilatation Catheter
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510(K) Number: K143480
Device Name: Euphora Rapid Exchange Balloon Dilatation Catheter
Manufacturer: MEDTRONIC INC.
Device Classification Name: catheters, transluminal coronary angioplasty, percutaneous
Regulation Number: 870.5100
Classification Product Code: LOX
Date Received: 12/08/2014
Decision Date: 04/02/2015
Regulation Medical Specialty: Cardiovascular
Device Name: Euphora Rapid Exchange Balloon Dilatation Catheter
Manufacturer: MEDTRONIC INC.
Device Classification Name: catheters, transluminal coronary angioplasty, percutaneous
Regulation Number: 870.5100
Classification Product Code: LOX
Date Received: 12/08/2014
Decision Date: 04/02/2015
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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