FDA 510(k) Application Details - K050558

Device Classification Name Filter, Intravascular, Cardiovascular

  More FDA Info for this Device
510(K) Number K050558
Device Name Filter, Intravascular, Cardiovascular
Applicant C.R. BARD, INC.
1625 WEST 3RD ST.
TEMPE, AZ 85281-1740 US
Other 510(k) Applications for this Company
Contact KAREN HUTCHISON
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 03/03/2005
Decision Date 08/29/2005
Decision SESU - SE - WITH LIMITATIONS
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