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510(k) Data Aggregation
K Number
K221694Device Name
External Drainage System
Manufacturer
JMED(Shenzhen) Technology Limited
Date Cleared
2023-02-09
(244 days)
Product Code
JXG
Regulation Number
882.5550Why did this record match?
Applicant Name (Manufacturer) :
JMED(Shenzhen) Technology Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
External Drainage System allows for drainage of cerebrospinal fluid (CSF) from the lateral ventricles of the brain and the lumbar subarachnoid space in selected patients to reduce intracranial pressure (ICP).
Device Description
The External Drainage System includes a tubing, drainage bag, drip chamber and scale plate. It is provided sterile and can be connected to a drainage catheter, which is connected to a patient line, via a luer connection and ultimately to a drainage bag. The drainage catheter is not included in the subject device. The External Drainage System provides a closed system for the drainage of cerebrospinal fluid (CSF) from the ventricles of the brain or the lumbar subarachnoid space. During the draining, the cerebrospinal fluid will be collected in a drainage bag.
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