• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
510(k) Number K113845
Device Name TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE
Original Applicant
MEDTRONIC INC.
7611 northland drive
minneapolis,  MN  55428
Original Contact kevin t lam
Regulation Number870.4290
Classification Product Code
DTL  
Subsequent Product Code
DWF  
Date Received12/28/2011
Decision Date 01/25/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
-
-