FDA 510(k) Application Details - K123156

Device Classification Name	Temporary Carotid Catheter For Embolic Capture   More FDA Info for this Device
510(K) Number	K123156
Device Name	Temporary Carotid Catheter For Embolic Capture
Applicant	W. L. GORE & ASSOCIATES, INC. 32360 N NORTH VALLEY PARKWAY PHOENIX, AZ 85085 US Other 510(k) Applications for this Company
Contact	SHARON ALEXANDER 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	10/09/2012
Decision Date	12/13/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review