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FDA 510(k), K111705, EKOSONIC ENDOVASCULAR SYSTEM
FDA 510(k), K111705, EKOSONIC ENDOVASCULAR SYSTEM
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510(K) Number: K111705
Device Name: EKOSONIC ENDOVASCULAR SYSTEM
Manufacturer: EKOS CORPORATION
Device Classification Name: mechanical thrombolysis catheter
Regulation Number: 870.5150
Classification Product Code: QEY
Date Received: 06/17/2011
Decision Date: 08/03/2011
Regulation Medical Specialty: Cardiovascular
Device Name: EKOSONIC ENDOVASCULAR SYSTEM
Manufacturer: EKOS CORPORATION
Device Classification Name: mechanical thrombolysis catheter
Regulation Number: 870.5150
Classification Product Code: QEY
Date Received: 06/17/2011
Decision Date: 08/03/2011
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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