510(k) K981046

MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR CATHETER, 20CM AND 35 CM MODEL # 96115 AND 96118 by Medtronic PS Medical — Product Code JXG

K981046 is an FDA 510(k) premarket notification submitted by Medtronic PS Medical for the device "MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR CATHETER, 20CM AND 35 CM MODEL # 96115 AND 96118". The FDA issued a decision of Substantially Equivalent on June 16, 1998. 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.