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FDA 510(k), K141139, SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER
FDA 510(k), K141139, SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER
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510(K) Number: K141139
Device Name: SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER
Manufacturer: ZOLL CIRCULATION
Device Classification Name: system, hypothermia, intravenous, cooling
Regulation Number: 870.5900
Classification Product Code: NCX
Date Received: 05/02/2014
Decision Date: 10/03/2014
Regulation Medical Specialty: Cardiovascular
Device Name: SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER
Manufacturer: ZOLL CIRCULATION
Device Classification Name: system, hypothermia, intravenous, cooling
Regulation Number: 870.5900
Classification Product Code: NCX
Date Received: 05/02/2014
Decision Date: 10/03/2014
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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