FDA 510(k) Application Details - K972484

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K972484
Device Name	Catheter, Percutaneous
Applicant	GUIDANT CORP. 3200 LAKESIDE DR. P.O. BOX 58167 SANTA CLARA, CA 95052-8167 US Other 510(k) Applications for this Company
Contact	Sara Toyloy Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/1997
Decision Date	09/26/1997
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