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FDA 510(k), K102726, CARDIOHELP SYSTEM
FDA 510(k), K102726, CARDIOHELP SYSTEM
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510(K) Number: K102726
Device Name: CARDIOHELP SYSTEM
Manufacturer: ROLAND JEHLE
Device Classification Name: Console, Heart-Lung Machine, Cardiopulmonary Bypass
Regulation Number: DTQ
Classification Product Code: 09/21/2010
Date Received: 04/04/2011
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: CARDIOHELP SYSTEM
Manufacturer: ROLAND JEHLE
Device Classification Name: Console, Heart-Lung Machine, Cardiopulmonary Bypass
Regulation Number: DTQ
Classification Product Code: 09/21/2010
Date Received: 04/04/2011
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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