EVAC-MRI
K-Number: K252514 · 2025-11-05
ApplicantPhasor Health, LLC
Decision Date2025-11-05
Product CodeJXG
Advisory CommitteeNE
DecisionUnknown
Device Summary
EVAC-MRI is a medical device manufactured by Phasor Health, LLC. It received FDA 510(k) clearance on 2025-11-05 under approval number K252514. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Unknown.
Frequently Asked Questions
What is the EVAC-MRI?
EVAC-MRI is a medical device that received FDA 510(k) clearance on 2025-11-05. It is manufactured by Phasor Health, LLC. The 510(k) number is K252514.
When was EVAC-MRI approved by the FDA?
EVAC-MRI received FDA 510(k) clearance on 2025-11-05, under approval number K252514.
What company makes EVAC-MRI?
EVAC-MRI is manufactured by Phasor Health, LLC.
What is the FDA product code for EVAC-MRI?
The FDA product code for EVAC-MRI is JXG.
Other Devices by Phasor Health, LLC
Related Devices (Code: JXG)
K162437Codman EDS3 CSF External Drainage SystemCodman & Shurtleff, Inc.
K161605Smart External Drain (SED) SystemAqueduct Critical Care, Inc.
K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt SystemsIntegra LifeSciences Corporation
K152700StrataMR Valves and ShuntsMedtronic Neurosurgery
K153041Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional LabelingIntegra LifeSciences Corporation
K152897Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating AccessoryIntegra LifeSciences Corporation
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.