510(k) K103715

COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE by Mirador Biomedical, Inc. — Product Code DRS

K103715 is an FDA 510(k) premarket notification submitted by Mirador Biomedical, Inc. for the device "COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE". The FDA issued a decision of Substantially Equivalent on January 20, 2011. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Mirador Biomedical, Inc. has at least 3 other 510(k) clearances on record.