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 System, Perfusion, Kidney
510(k) Number K261644
Device Name Perfadex Plus
Applicant
Xvivo Perfusion AB
Entreprenörsstråket 10
Mölndal,  SE SE-431 53
Applicant Contact Petra Rosen
Correspondent
Xvivo Perfusion AB
Entreprenörsstråket 10
Mölndal,  SE SE-431 53
Correspondent Contact Petra Rosen
Regulation Number876.5880
Classification Product Code
KDN  
Date Received05/18/2026
Decision Date 07/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-