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FDA 510(k), K142983, AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating
FDA 510(k), K142983, AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating
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$149.00 USD
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510(K) Number: K142983
Device Name: AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating
Manufacturer: ANGIOSCORE, INC.
Device Classification Name: Catheter, Percutaneous, Cutting/Scoring
Regulation Number: 870.1250
Classification Product Code: PNO
Date Received: 10/16/2014
Decision Date: 03/04/2015
Regulation Medical Specialty: Cardiovascular
Device Name: AngioSculpt PTA Scoring Balloon Catheter with HydroCross Coating
Manufacturer: ANGIOSCORE, INC.
Device Classification Name: Catheter, Percutaneous, Cutting/Scoring
Regulation Number: 870.1250
Classification Product Code: PNO
Date Received: 10/16/2014
Decision Date: 03/04/2015
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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