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FDA 510(k), K190650, Revolution Centrifugal Blood Pump
FDA 510(k), K190650, Revolution Centrifugal Blood Pump
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$149.00 USD
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510(K) Number: K190650
Device Name: Revolution Centrifugal Blood Pump
Manufacturer: SORIN GROUP ITALIA S.R.L.
Device Classification Name: pump, blood, cardiopulmonary bypass, non-roller type
Regulation Number: 870.4360
Classification Product Code: KFM
Date Received: 03/13/2019
Decision Date: 08/07/2019
Regulation Medical Specialty: Cardiovascular
Device Name: Revolution Centrifugal Blood Pump
Manufacturer: SORIN GROUP ITALIA S.R.L.
Device Classification Name: pump, blood, cardiopulmonary bypass, non-roller type
Regulation Number: 870.4360
Classification Product Code: KFM
Date Received: 03/13/2019
Decision Date: 08/07/2019
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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