FDA 510(k) Application Details - K081576

Device Classification Name	Catheter, Electrode Recording, Or Probe, Electrode Recording   More FDA Info for this Device
510(K) Number	K081576
Device Name	Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant	BOSTON SCIENTIFIC CORP. 150 BAYTECH DRIVE SAN JOSE, CA 95134 US Other 510(k) Applications for this Company
Contact	RONALD C ALLEN 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	06/05/2008
Decision Date	02/03/2009
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