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FDA 510(k), K152665, PolarCath Peripheral Dilatation System
FDA 510(k), K152665, PolarCath Peripheral Dilatation System
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510(K) Number: K152665
Device Name: PolarCath Peripheral Dilatation System
Manufacturer: NUCYRO VASCULAR, LLC
Device Classification Name: catheter, angioplasty, peripheral, transluminal
Regulation Number: 870.1250
Classification Product Code: LIT
Date Received: 09/17/2015
Decision Date: 10/26/2015
Regulation Medical Specialty: Cardiovascular
Device Name: PolarCath Peripheral Dilatation System
Manufacturer: NUCYRO VASCULAR, LLC
Device Classification Name: catheter, angioplasty, peripheral, transluminal
Regulation Number: 870.1250
Classification Product Code: LIT
Date Received: 09/17/2015
Decision Date: 10/26/2015
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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