FDA 510(k) Application Details - K160651

Device Classification Name Set, Administration, Intravascular

  More FDA Info for this Device
510(K) Number K160651
Device Name Set, Administration, Intravascular
Applicant BECTON, DICKINSON AND COMPANY
1 BECTON DRIVE
Franklin Lakes, NJ 07666 US
Other 510(k) Applications for this Company
Contact Matthew Trachtenberg
Other 510(k) Applications for this Contact
Regulation Number 880.5440

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

  More FDA Info for this Product Code
Date Received 03/08/2016
Decision Date 04/07/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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