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FDA 510(k), K081467, EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
FDA 510(k), K081467, EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
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510(K) Number: K081467
Device Name: EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
Manufacturer: EKOS CORP.
Device Classification Name: Mechanical Thrombolysis Catheter
Regulation Number: 870.5150
Classification Product Code: QEY
Date Received: 05/27/2008
Decision Date: 06/26/2008
Regulation Medical Specialty: Cardiovascular
Device Name: EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
Manufacturer: EKOS CORP.
Device Classification Name: Mechanical Thrombolysis Catheter
Regulation Number: 870.5150
Classification Product Code: QEY
Date Received: 05/27/2008
Decision Date: 06/26/2008
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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