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FDA 510(k), K110389, STEALTH 360 ORBITAL PAD SYSTEM
FDA 510(k), K110389, STEALTH 360 ORBITAL PAD SYSTEM
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510(K) Number: K110389
Device Name: STEALTH 360 ORBITAL PAD SYSTEM
Manufacturer: CARDIOVASCULAR SYSTEMS, INC.
Device Classification Name: catheter, peripheral, atherectomy
Regulation Number: 870.4875
Classification Product Code: MCW
Date Received: 02/10/2011
Decision Date: 03/11/2011
Regulation Medical Specialty: Cardiovascular
Device Name: STEALTH 360 ORBITAL PAD SYSTEM
Manufacturer: CARDIOVASCULAR SYSTEMS, INC.
Device Classification Name: catheter, peripheral, atherectomy
Regulation Number: 870.4875
Classification Product Code: MCW
Date Received: 02/10/2011
Decision Date: 03/11/2011
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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