FDA 510(k) Application Details - K102633

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K102633
Device Name	Catheter, Intravascular, Diagnostic
Applicant	BIOTEQUE CORP. 2904 N BOLDT DRIVE FLAGSTAFF, AZ 86001 US Other 510(k) Applications for this Company
Contact	JENNIFER REICH Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/13/2010
Decision Date	09/09/2011
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