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FDA 510(k), K030742, POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
FDA 510(k), K030742, POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
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510(K) Number: K030742
Device Name: POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
Manufacturer: CRYO VASCULAR SYSTEMS INC.
Device Classification Name: catheter, angioplasty, peripheral, transluminal
Regulation Number: 870.1250
Classification Product Code: LIT
Date Received: 03/10/2003
Decision Date: 08/29/2003
Regulation Medical Specialty: Cardiovascular
Device Name: POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
Manufacturer: CRYO VASCULAR SYSTEMS INC.
Device Classification Name: catheter, angioplasty, peripheral, transluminal
Regulation Number: 870.1250
Classification Product Code: LIT
Date Received: 03/10/2003
Decision Date: 08/29/2003
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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