FDA 510(k) Application Details - K081881

Device Classification Name	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K081881
Device Name	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant	GISH BIOMEDICAL, INC. 22942 ARROYO VISTA RANCHO SANTA MARGARITA, CA 92688 US Other 510(k) Applications for this Company
Contact	EDWARD F WADDELL Other 510(k) Applications for this Contact
Regulation Number	870.4210   More FDA Info for this Regulation Number
Classification Product Code	DWF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2008
Decision Date	01/23/2009
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