FDA 510(k) Application Details - K073523

Device Classification Name Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection

  More FDA Info for this Device
510(K) Number K073523
Device Name Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Applicant MEDTRONIC INC.
37A CHERRY HILL DRIVE
DANVERS, MA 01923 US
Other 510(k) Applications for this Company
Contact COLLEEN MULLINS
Other 510(k) Applications for this Contact
Regulation Number 870.1250

  More FDA Info for this Regulation Number
Classification Product Code NFA
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 12/14/2007
Decision Date 08/01/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact