510(k) K012052

MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855 by Medtronic PS Medical — Product Code JXG

K012052 is an FDA 510(k) premarket notification submitted by Medtronic PS Medical for the device "MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855". The FDA issued a decision of Substantially Equivalent on February 11, 2002. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Medtronic PS Medical has at least 10 other 510(k) clearances on record.