FDA 510(k) Application Details - K121234

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K121234
Device Name	Introducer, Catheter
Applicant	W. L. GORE & ASSOCIATES, INC. 3450 KILTIE LANE P.O. BOX 2400 FLAGSTAFF, AZ 86003-2400 US Other 510(k) Applications for this Company
Contact	ALICIA L HEMPHILL Other 510(k) Applications for this Contact
Regulation Number	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/2012
Decision Date	11/20/2012
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