MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR CATHETER, 20CM AND 35 CM MODEL # 96115 AND 96118

MEDTRONIC PS MEDICAL EXTERNAL DRAINAGE AND MONITORING (EDM) VENTRICULAR CATHETER, 20CM AND 35 CM MODEL # 96115 AND 96118 is an FDA 510(k)-cleared medical device (K981046) manufactured by Medtronic PS Medical. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 15, 1998. Regulation: 8.