FDA 510(k) Application Details - K022857

Device Classification Name	Tubing, Pump, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K022857
Device Name	Tubing, Pump, Cardiopulmonary Bypass
Applicant	Terumo Cardiovascular Systems Corporation 125 BLUE BALL RD. ELKTON, MD 21921 US Other 510(k) Applications for this Company
Contact	KAZUHITO INOUE Other 510(k) Applications for this Contact
Regulation Number	870.4390   More FDA Info for this Regulation Number
Classification Product Code	DWE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/2002
Decision Date	09/19/2002
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