510(k) K983799

MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL by Medtronic PS Medical — Product Code GWM

K983799 is an FDA 510(k) premarket notification submitted by Medtronic PS Medical for the device "MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL". The FDA issued a decision of Substantially Equivalent on January 26, 1999. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Medtronic PS Medical has at least 10 other 510(k) clearances on record.