FDA 510(k) Application Details - K110347

Device Classification Name	Flowmeter, Blood, Cardiovascular   More FDA Info for this Device
510(K) Number	K110347
Device Name	Flowmeter, Blood, Cardiovascular
Applicant	COOK VASCULAR, INC. 1186 MONTGOMERY LANE VANDERGRIFT, PA 15690 US Other 510(k) Applications for this Company
Contact	JIM FERGUSON Other 510(k) Applications for this Contact
Regulation Number	870.2100   More FDA Info for this Regulation Number
Classification Product Code	DPW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/07/2011
Decision Date	03/16/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review