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FDA 510(k), K140151, EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT
FDA 510(k), K140151, EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT
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510(K) Number: K140151
Device Name: EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT
Manufacturer: JOCELYN KERSTEN
Device Classification Name: Mechanical Thrombolysis Catheter
Regulation Number: QEY
Classification Product Code: 01/22/2014
Date Received: 05/21/2014
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT
Manufacturer: JOCELYN KERSTEN
Device Classification Name: Mechanical Thrombolysis Catheter
Regulation Number: QEY
Classification Product Code: 01/22/2014
Date Received: 05/21/2014
Decision Date: Substantially Equivalent (SESE)
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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