FDA 510(k) Application Details - K100789

Device Classification Name	Catheter, Steerable   More FDA Info for this Device
510(K) Number	K100789
Device Name	Catheter, Steerable
Applicant	EVALVE INC 4045 CAMPBELL AVENUE MENLO PARK, CA 94025 US Other 510(k) Applications for this Company
Contact	KARUNA VELUSAMY Other 510(k) Applications for this Contact
Regulation Number	870.1280   More FDA Info for this Regulation Number
Classification Product Code	DRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/22/2010
Decision Date	04/21/2010
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