FDA 510(k) Application Details - K993245

Device Classification Name	Catheter, Flow Directed   More FDA Info for this Device
510(K) Number	K993245
Device Name	Catheter, Flow Directed
Applicant	ALBA CRITICAL CARE LTD PHOENIX CRESCENT STRATHCLYDE BUSINESS PARK BELLSHILL, LANARKSHIRE ML4 3NJ GB Other 510(k) Applications for this Company
Contact	TED VANDER WIEDE Other 510(k) Applications for this Contact
Regulation Number	870.1240   More FDA Info for this Regulation Number
Classification Product Code	DYG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/1999
Decision Date	10/28/1999
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