510(k) K991502

MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022 by Medtronic PS Medical — Product Code JXG

K991502 is an FDA 510(k) premarket notification submitted by Medtronic PS Medical for the device "MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022". The FDA issued a decision of Substantially Equivalent on September 12, 2000. 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.