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FDA 510(k), K150267, QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators
FDA 510(k), K150267, QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators
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$149.00 USD
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510(K) Number: K150267
Device Name: QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators
Manufacturer: Whitney Torning
Device Classification Name: Oxygenator, Cardiopulmonary Bypass
Regulation Number: DTZ
Classification Product Code: 02/04/2015
Date Received: 05/07/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators
Manufacturer: Whitney Torning
Device Classification Name: Oxygenator, Cardiopulmonary Bypass
Regulation Number: DTZ
Classification Product Code: 02/04/2015
Date Received: 05/07/2015
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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