FDA 510(k) Application Details - K152709

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K152709
Device Name	Wire, Guide, Catheter
Applicant	ABBOTT VASCULAR 26531 YNEZ ROAD TEMECULA, CA 92591 US Other 510(k) Applications for this Company
Contact	JOCHEN REICH 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	09/21/2015
Decision Date	10/21/2015
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