510(k) K984053

BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM by Medtronic PS Medical — Product Code JXG

K984053 is an FDA 510(k) premarket notification submitted by Medtronic PS Medical for the device "BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on February 4, 1999. 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.