Medtronic PS Medical Niveau Drainage System, Medtronic PS Medical Niveau Drainage System Pole Clamp, Medtronic PS Medicl

FDA 510(k) K983799 · Medtronic PS Medical

Substantially Equivalent

510(k) numberK983799

Submission

Device name
Medtronic PS Medical Niveau Drainage System, Medtronic PS Medical Niveau Drainage System Pole Clamp, Medtronic PS Medicl
Applicant
Medtronic PS Medical
Goleta, CA, US
Received
October 28, 1998
Decision date
January 26, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GWM – Device, Monitoring, Intracranial Pressure
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1620
Specialty
Neurology

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K240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)GWM · Traditional Braincare Desenvolvimento E Inovação Tecnológica…07/18/2024SE
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K201118Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta…GWM · Special Medtronic, Inc.05/26/2020SE
K200630Medtronic External Drainage and Monitoring System, Medtronic External Drainage and…GWM · Special Medtronic, Inc.04/09/2020SE
K200456Becker External Drainage and Monitoring SystemGWM · Special Medtronic, Inc.03/26/2020SE
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More from Braincare Desenvolvimento E Inovacao Tecnologica S.A.

510(k)DeviceDecision
K012052Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855JXG · Traditional 02/11/2002SE
K010361Medtronic PS Medical Invisx Cranial Fixation System, Model 60100-60900GXR · Traditional 05/07/2001SE
K010487Bipolar Pencil, Model 3901-002, 3900-002GEI · Abbreviated 05/03/2001SE
K010341Medtronic PS Medical Murphyscope, Models 2125-032, 2125033,2125-042, 2125-043, 2125-157…GWG · Abbreviated 04/20/2001SE
K003914Medtronic PS Medical Neuropen Endoscope and Optical AccessoriesGWG · Abbreviated 02/22/2001SE
K002572Medtronic PS Medical Channelscope Endoscope, Models 2232-001, 2232-002, 2232-003…GWG · Abbreviated 11/16/2000SE
K991502Medtronic PS Medical Polyurethane Shunt, Models 27521, 27116, 20022JXG · Traditional 09/12/2000SE
K990333Medtronic PS Medical Introducer Sheath 12F,14F,15F, Models 3805-012, 3805-014, 3805-015GWG · Traditional 04/28/1999SE
K984053Becker External Drainage and Monitoring SystemJXG · Traditional 02/04/1999SE
K983331Medtronic PS Medical Innervision Ventricular Catheter, 15CM Model 99102HCA · Traditional 12/16/1998SE

Questions and answers

When was Medtronic PS Medical Niveau Drainage System, Medtronic PS Medical Niveau Drainage System Pole Clamp, Medtronic PS Medicl cleared by the FDA?

Medtronic PS Medical Niveau Drainage System, Medtronic PS Medical Niveau Drainage System Pole Clamp, Medtronic PS Medicl (K983799) received a 510(k) decision of Substantially Equivalent on January 26, 1999, 90 days after the submission was received.

What is the product code of K983799?

The FDA product code is GWM – Device, Monitoring, Intracranial Pressure, a Class II (moderate risk) device regulated under 21 CFR 882.1620.