510(k) K033424

ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002 by Transonic Systems, Inc. — Product Code DPW

K033424 is an FDA 510(k) premarket notification submitted by Transonic Systems, Inc. for the device "ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002". The FDA issued a decision of Substantially Equivalent on December 11, 2003. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Transonic Systems, Inc. has at least 10 other 510(k) clearances on record.