FDA 510(k) Application Details - K982876

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K982876
Device Name	Wire, Guide, Catheter
Applicant	GUIDANT CORP. 3200 LAKESIDE DR. SANTA CLARA, CA 95054-2807 US Other 510(k) Applications for this Company
Contact	SUSAN SILAVIN 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	08/14/1998
Decision Date	11/10/1998
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