FDA 510(k) Application Details - K103377

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K103377
Device Name	Wire, Guide, Catheter
Applicant	BRIVANT, LTD. PARKMORE WEST BUSINESS PARK GALWAY EI IE Other 510(k) Applications for this Company
Contact	TOMAS FUREY Other 510(k) Applications for this Contact
Regulation Number	870.1330   More FDA Info for this Regulation Number
Classification Product Code	DQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/17/2010
Decision Date	05/18/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review