StrataMR Valves and Shunts— 510(k) K152700

Clearance details

Applicant

Medtronic Neurosurgery

Product code

Code JXG

Device class

Class 2

Regulation

21 CFR 882.5550

Advisory panel

Neurology

Date received

2015-09-21

Decision date

2016-04-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Goleta, CA, US

• K261004 — Codman® Distal Peritoneal Catheter, Barium Open End (82-1682) +1 more2026-06-23
• K251598 — Intellidrop2025-12-10
• K250636 — Sophy Mini Monopressure Valve (SM1)2025-11-28
• K252514 — EVAC-MRI2025-11-05
• K243531 — Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology2025-08-08

• K243676 — Duet External Drainage and Monitoring System (EDMS)2025-03-10
• K242034 — Duet External Drainage and Monitoring System (EDMS)2024-10-24
• K212641 — StrataMR II Valves and Shunts2021-09-16
• K181622 — StrataMR guider tool2018-10-01
• K161370 — Durepair Dura Regeneration Matrix2016-11-02

Death

76

Injury

5,632

Malfunction

2,230

Other

4

Total

7,942

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1702-2017 — The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to non-invasive adjust valve pressure/performance level pre- and post-implantation by using magnetic adjustment tools without the need for radiographic confirmation. After surgical implantation, the Medtronic Neurosurgery StrataMR valves provide a non-invasive method to address changing patient needs in the management of hydrocephalus. The valve design enables the physician to adjust the valve pressure/performance level using the Medtronic StrataMR Adjustment Tools. The StrataMR valves are intended to maintain performance level setting under magnetic resonance imaging (MRI) exposure when scanned in accordance with the MRI conditions in the labeling. The StrataMR valves, small and regular, provide the full range of performance levels: 0.5, 1.0, 1.5, 2.0, and 2.5. The currently set performance level is discernible through use of the Indicator Tool or by x-ray (for corresponding settings, refer to figure 6). The dome is designed to allow needle puncture via a 25-gauge or smaller noncoring needle. The StrataMR valve can be flushed in either the distal or proximal direction by percutaneous finger pressure. Occluders are located proximally and distally to the central reservoir on the StrataMR valve regular and only distally on the small model to facilitate selective flushing.Class I·Terminated·Medtronic Neurosurgery·20170222

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152700.