FDA 510(k) Application Details - K143015

Device Classification Name Set, Administration, Intravascular

  More FDA Info for this Device
510(K) Number K143015
Device Name Set, Administration, Intravascular
Applicant Hospira, Inc.
375 North Field Drive
Lake Forest, IL 60045 US
Other 510(k) Applications for this Company
Contact Anju Kurian
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 10/20/2014
Decision Date 02/25/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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