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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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