FDA 510(k) Application Details - K112381

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K112381
Device Name	Wire, Guide, Catheter
Applicant	LAKE REGION MEDICAL LAKE REGION MED INTL R&D CTR PARKMORE WEST BUSINESS GALWAY EI IE Other 510(k) Applications for this Company
Contact	KENNY WALSH 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	08/17/2011
Decision Date	11/03/2011
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