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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K171530
Device Name Deltaven XiV Max, Deltaven XiV Max FF
Applicant
Delta Med SpA
Via Guido Rossa N 20
Viadana,  IT 46019
Applicant Contact Raschi Olga
Correspondent
Donawa Lifescience Consulting Srl
Piazza Albania, N 10
Rome,  IT 00153
Correspondent Contact Roger Gray
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received05/25/2017
Decision Date 12/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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