FDA 510(k) Application Details - K183174

Device Classification Name	Catheter, Steerable   More FDA Info for this Device
510(K) Number	K183174
Device Name	Catheter, Steerable
Applicant	Medtronic CryoCath LP 8200 Coral Sea Street NE MVS 46 Mounds View, MN 55112 US Other 510(k) Applications for this Company
Contact	Natalie Sadeghi Other 510(k) Applications for this Contact
Regulation Number	870.1280   More FDA Info for this Regulation Number
Classification Product Code	DRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/16/2018
Decision Date	11/26/2018
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