FDA 510(k) Application Details - K081804

Device Classification Name	More FDA Info for this Device
510(K) Number	K081804
Device Name	PIONEER PLUS CATHETER
Applicant	MEDTRONIC INC. 3576 Unocal Place Santa Rosa, CA 95403 US Other 510(k) Applications for this Company
Contact	CATHERINE PRIESTLEY Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/26/2008
Decision Date	08/05/2008
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