FDA 510(k) Application Details - K042984

Device Classification Name	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K042984
Device Name	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant	INTERVASCULAR 690 CANTON STREET SUITE 302 WESTWOOD, MA 02090 US Other 510(k) Applications for this Company
Contact	Amy Aulwes 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	10/29/2004
Decision Date	02/18/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review