FDA 510(k), K112513, EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER

FDA 510(k), K112513, EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER

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510(K) Number: K112513
Device Name: EBONY PTA 0.014 PERIPHERAL DILATATION CATHETER
Manufacturer: NATEC MEDICAL LTD
Device Classification Name: catheter, angioplasty, peripheral, transluminal
Regulation Number: 870.1250
Classification Product Code: LIT
Date Received: 08/30/2011
Decision Date: 12/09/2011
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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