510(k) K023848

MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64: by Igc-Medical Advances, Inc. — Product Code MOS

K023848 is an FDA 510(k) premarket notification submitted by Igc-Medical Advances, Inc. for the device "MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:". The FDA issued a decision of Substantially Equivalent on Feb 14, 2003. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Igc-Medical Advances, Inc. has 6 other 510(k) clearances on record.