FDA 510(k) Application Details - K023833

Device Classification Name	Filter, Blood, Cardiopulmonary Bypass, Arterial Line   More FDA Info for this Device
510(K) Number	K023833
Device Name	Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Applicant	GISH BIOMEDICAL, INC. 11874 SOUTH EVELYN CIRCLE HOUSTON, TX 77071 US Other 510(k) Applications for this Company
Contact	J. HARVEY KNAUSS Other 510(k) Applications for this Contact
Regulation Number	870.4260   More FDA Info for this Regulation Number
Classification Product Code	DTM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/2002
Decision Date	03/31/2003
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