510(k) K191400

Voyager Trajectory Array Guide (V-TAG) by Mri Interventions, Inc. — Product Code HAW

K191400 is an FDA 510(k) premarket notification submitted by Mri Interventions, Inc. for the device "Voyager Trajectory Array Guide (V-TAG)". The FDA issued a decision of Substantially Equivalent on June 21, 2019. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Mri Interventions, Inc. has at least 10 other 510(k) clearances on record.