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 Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
510(k) Number K062870
Device Name TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03
Applicant
Kensey Nash Corp.
735 Pennsylvania Dr.
Exton,  PA  19341
Applicant Contact ROBIN M FATZINGER
Correspondent
Kensey Nash Corp.
735 Pennsylvania Dr.
Exton,  PA  19341
Correspondent Contact ROBIN M FATZINGER
Regulation Number870.1250
Classification Product Code
NFA  
Date Received09/25/2006
Decision Date 10/20/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-