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FDA 510(k), K162771, EkoSonic Endovascular System with Control Unit 4.0
FDA 510(k), K162771, EkoSonic Endovascular System with Control Unit 4.0
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510(K) Number: K162771
Device Name: EkoSonic Endovascular System with Control Unit 4.0
Manufacturer: BTG International, Inc.
Device Classification Name: mechanical thrombolysis catheter
Regulation Number: 870.5150
Classification Product Code: QEY
Date Received: 10/03/2016
Decision Date: 02/24/2017
Regulation Medical Specialty: Cardiovascular
Device Name: EkoSonic Endovascular System with Control Unit 4.0
Manufacturer: BTG International, Inc.
Device Classification Name: mechanical thrombolysis catheter
Regulation Number: 870.5150
Classification Product Code: QEY
Date Received: 10/03/2016
Decision Date: 02/24/2017
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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