FDA 510(k) Application Details - K040010

Device Classification Name	More FDA Info for this Device
510(K) Number	K040010
Device Name	GENESIS MEDICAL INTERVENTIONAL F.A.S.T. (FACILITATED ASPIRATION/SUCTION THROMBECTOMY) SYSTEMS
Applicant	GENESIS MEDICAL INTERVENTIONAL, INC. 652 BAIR ISLAND ROAD SUITE 103 REDWOOD CITY, CA 94063 US Other 510(k) Applications for this Company
Contact	ANNE WORDEN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/05/2004
Decision Date	07/19/2004
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