FDA 510(k) Application Details - K020316

Device Classification Name Catheter, Intravascular, Diagnostic

  More FDA Info for this Device
510(K) Number K020316
Device Name Catheter, Intravascular, Diagnostic
Applicant CORDIS CORP.
7 POWDER HORN DR.
WARREN, NJ 07059 US
Other 510(k) Applications for this Company
Contact KAREN WILK
Other 510(k) Applications for this Contact
Regulation Number 870.1200

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

  More FDA Info for this Product Code
Date Received 01/30/2002
Decision Date 03/20/2002
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