Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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
-
-