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
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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