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FDA 510(k), K133399, DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
FDA 510(k), K133399, DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
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510(K) Number: K133399
Device Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Manufacturer: CARDIOVASCULAR SYSTEMS INCORPORATED
Device Classification Name: catheter, peripheral, atherectomy
Regulation Number: 870.4875
Classification Product Code: MCW
Date Received: 11/06/2013
Decision Date: 11/22/2013
Regulation Medical Specialty: Cardiovascular
Device Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
Manufacturer: CARDIOVASCULAR SYSTEMS INCORPORATED
Device Classification Name: catheter, peripheral, atherectomy
Regulation Number: 870.4875
Classification Product Code: MCW
Date Received: 11/06/2013
Decision Date: 11/22/2013
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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