FDA 510(k) Application Details - K021015

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K021015
Device Name	Catheter, Intravascular, Diagnostic
Applicant	ACIST MEDICAL SYSTEMS 7450 FLYING CLOUDS DR. SUITE 150 EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	CARL M BEAURLINE Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/29/2002
Decision Date	04/26/2002
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