FDA.reportPublic FDA data

510(k) K252514

Device
EVAC-MRI
Applicant
Phasor Health, LLC
510(k) number
K252514
Product code
JXG
Decision
Unknown (SESD)
Decision date
2025-11-05
Date received
2025-08-11
Regulation
882.5550
Classification name
Shunt, Central Nervous System And Components
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ray King
Address
8944 Kirby Dr. Houston TX US 77054 77054

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular CatheterIntegra Lifesciences Production Corporation2024-01-17
K233448Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter SetIntegra Lifesciences Production Corporation2023-12-19
K231664IRRAflow Active Fluid Exchange System (AFES)Irras USA, Inc.2023-10-19
K221694External Drainage SystemJmed(Shenzhen) Technology Limited2023-02-09
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K223330Certas Plus Programmable ValvesIntegra Lifesciences Production Corporation2023-02-01