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FDA 510(k), K132829, QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
FDA 510(k), K132829, QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
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$149.00 USD
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510(K) Number: K132829
Device Name: QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
Manufacturer: WHITNEY TORNING
Device Classification Name: Oxygenator, Cardiopulmonary Bypass
Regulation Number: DTZ
Classification Product Code: 09/09/2013
Date Received: 10/08/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
Manufacturer: WHITNEY TORNING
Device Classification Name: Oxygenator, Cardiopulmonary Bypass
Regulation Number: DTZ
Classification Product Code: 09/09/2013
Date Received: 10/08/2013
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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