• 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 Console, Heart-Lung Machine, Cardiopulmonary Bypass
510(k) Number K052555
Device Name MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB
Applicant
RAND S.R.L.
7611 NORTHLAND DRIVE
MINNEAPOLIS,  MN  55428
Applicant Contact PREETI JAIN
Correspondent
RAND S.R.L.
7611 NORTHLAND DRIVE
MINNEAPOLIS,  MN  55428
Correspondent Contact PREETI JAIN
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received09/16/2005
Decision Date 03/15/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-