FDA 510(k) Application Details - K082343

Device Classification Name	More FDA Info for this Device
510(K) Number	K082343
Device Name	VASCUTRAK 2, MODELS: V14 AND V18
Applicant	YMED INC. 9951-B BUSINESS PARK AVE. SAN DIEGO, CA 92131 US Other 510(k) Applications for this Company
Contact	THOMAS SCHROEDER Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/2008
Decision Date	09/11/2008
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