FDA 510(k) Application Details - K031518

Device Classification Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

  More FDA Info for this Device
510(K) Number K031518
Device Name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant MEDTRONIC VASCULAR
7611 NORTHLAND DR.
MINNEAPOLIS, MN 55428 US
Other 510(k) Applications for this Company
Contact DAWN STENSTROM
Other 510(k) Applications for this Contact
Regulation Number 870.4210

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

  More FDA Info for this Product Code
Date Received 05/15/2003
Decision Date 05/22/2003
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