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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
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
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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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