FDA 510(k) Application Details - K142684

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K142684
Device Name	Introducer, Catheter
Applicant	Medtronic CryoCath LP 8200 Coral Sea Street NE Mail Stop MVS46 Mounds View, MN 55112 US Other 510(k) Applications for this Company
Contact	Vanessa Ware Other 510(k) Applications for this Contact
Regulation Number	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/19/2014
Decision Date	11/06/2014
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