• 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 catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K113411
Device Name EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA
Original Applicant
EDWARDS LIFESCIENCES, LLC.
12050 lone peak pkwy
draper,  UT  84020
Original Contact dannette crooms
Regulation Number870.4210
Classification Product Code
DWF  
Date Received11/18/2011
Decision Date 06/11/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product Yes
-
-