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 Heart Valve, More Than Minimally Manipulated Allograft
510(k) Number K083106
Device Name CRYOVALVE SG PULMONARY VALVE AND CONDUIT
Applicant
Cryolife, Inc.
1655 Roberts Blvd., NW
Kennesaw,  GA  30144
Applicant Contact JOHN D FERROS
Correspondent
Cryolife, Inc.
1655 Roberts Blvd., NW
Kennesaw,  GA  30144
Correspondent Contact JOHN D FERROS
Classification Product Code
OHA  
Date Received10/20/2008
Decision Date 02/06/2009
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-