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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
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