FDA 510(k) Application Details - K033443

Device Classification Name	More FDA Info for this Device
510(K) Number	K033443
Device Name	SPEEDLYSER INFUSION CATHETER KIT
Applicant	ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. QUEENSBURY, NY 12804 US Other 510(k) Applications for this Company
Contact	TERI JUCKETT Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/29/2003
Decision Date	11/19/2003
Decision	SEKD - SUBST EQUIV - KIT WITH DRUGS
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review