FDA 510(k) Application Details - K102588

Device Classification Name	Catheter, Electrode Recording, Or Probe, Electrode Recording   More FDA Info for this Device
510(K) Number	K102588
Device Name	Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant	MEDTRONIC ABLATION FRONTIERS, LLC 2210 FARADAY AVENUE SUIT 100 CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	BRENDA CLAY Other 510(k) Applications for this Contact
Regulation Number	870.1220   More FDA Info for this Regulation Number
Classification Product Code	DRF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/2010
Decision Date	03/18/2011
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