• 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 patch, pledget and intracardiac, petp, ptfe, polypropylene
510(k) Number K082139
Device Name EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700
Original Applicant
EDWARDS LIFESCIENCES, LLC.
one edwards way
irvine,  CA  92614
Original Contact daryl richardson
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received07/29/2008
Decision Date 10/23/2008
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 No
-
-