FDA 510(k) Application Details - K001694

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K001694
Device Name	Catheter, Percutaneous
Applicant	GUIDANT CARDIAC AND VASCULAR SURGERY 1525 O'BRIEN DR. MENLO PARK, CA 94025 US Other 510(k) Applications for this Company
Contact	BERNICE JURS 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	06/02/2000
Decision Date	05/15/2001
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