FDA 510(k) Application Details - K083300

Device Classification Name	Temporary Carotid Catheter For Embolic Capture   More FDA Info for this Device
510(K) Number	K083300
Device Name	Temporary Carotid Catheter For Embolic Capture
Applicant	W.L. GORE & ASSOCIATES,INC 3250 W. KILTIE LANE FLAGSTAFF, AZ 86005 US Other 510(k) Applications for this Company
Contact	MICHELLE A WELLS Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	NTE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/10/2008
Decision Date	02/04/2009
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