FDA 510(k), K171530, Deltaven XiV Max, Deltaven XiV Max FF

FDA 510(k), K171530, Deltaven XiV Max, Deltaven XiV Max FF

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510(K) Number: K171530
Device Name: Deltaven XiV Max, Deltaven XiV Max FF
Manufacturer: Raschi Olga
Device Classification Name: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Regulation Number: FOZ
Classification Product Code: 05/25/2017
Date Received: 12/21/2017
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital

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