FDA 510(k) Application Details - K100470

Device Classification Name Wire, Guide, Catheter

  More FDA Info for this Device
510(K) Number K100470
Device Name Wire, Guide, Catheter
Applicant MEDTRONIC INC.
37A CHERRY HILL DRIVE
DANVERS, MA 01923 US
Other 510(k) Applications for this Company
Contact COLLEEN MULLINS
Other 510(k) Applications for this Contact
Regulation Number 870.1330

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

  More FDA Info for this Product Code
Date Received 02/18/2010
Decision Date 04/21/2010
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