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FDA 510(k), K071042, POLARCATH PERIPHERAL DILATATION SYSTEM
FDA 510(k), K071042, POLARCATH PERIPHERAL DILATATION SYSTEM
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510(K) Number: K071042
Device Name: POLARCATH PERIPHERAL DILATATION SYSTEM
Manufacturer: BOSTON SCIENTIFIC CORP.
Device Classification Name: catheter, angioplasty, peripheral, transluminal
Regulation Number: 870.1250
Classification Product Code: LIT
Date Received: 04/12/2007
Decision Date: 06/13/2007
Regulation Medical Specialty: Cardiovascular
Device Name: POLARCATH PERIPHERAL DILATATION SYSTEM
Manufacturer: BOSTON SCIENTIFIC CORP.
Device Classification Name: catheter, angioplasty, peripheral, transluminal
Regulation Number: 870.1250
Classification Product Code: LIT
Date Received: 04/12/2007
Decision Date: 06/13/2007
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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