FDA 510(k) Application Details - K091077

Device Classification Name Filter, Intravascular, Cardiovascular

  More FDA Info for this Device
510(K) Number K091077
Device Name Filter, Intravascular, Cardiovascular
Applicant CORDIS CORP., A JOHNSON & JOHNSON CO.
430 RTE 22 EAST
BRIDGEWATER, NJ 08807 US
Other 510(k) Applications for this Company
Contact KAREN WILK
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 04/14/2009
Decision Date 02/04/2010
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