510(k) K052209

VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01 by Vascular Control Systems, Inc. — Product Code DPW

K052209 is an FDA 510(k) premarket notification submitted by Vascular Control Systems, Inc. for the device "VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01". The FDA issued a decision of Substantially Equivalent on September 6, 2005. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Vascular Control Systems, Inc. has at least 8 other 510(k) clearances on record.