FDA 510(k) Application Details - K072240

Device Classification Name Filter, Intravascular, Cardiovascular

  More FDA Info for this Device
510(K) Number K072240
Device Name Filter, Intravascular, Cardiovascular
Applicant COOK, INC.
750 DANIELS WAY
P.O. BOX 489
BLOOMINGTON, IN 47402 US
Other 510(k) Applications for this Company
Contact MOLLY BUSENBARK
Other 510(k) Applications for this Contact
Regulation Number 870.3375

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

  More FDA Info for this Product Code
Date Received 08/13/2007
Decision Date 11/08/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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