FDA 510(k) Application Details - K081560

Device Classification Name	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K081560
Device Name	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant	VASCUTEK LTD. NEWMAINS AVE. INCHINNAN INDUSTRIAL ESTATE RENFREWSHIRE, SCOTLAND PA4 9RR GB Other 510(k) Applications for this Company
Contact	KAREN KELSO 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	06/03/2008
Decision Date	02/10/2009
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