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510(k) Data Aggregation
K Number
K170599Device Name
SureFlo EVD Catheter
Manufacturer
Arkis BioSciences Inc.
Date Cleared
2017-08-31
(183 days)
Product Code
JXG
Regulation Number
882.5550Why did this record match?
Applicant Name (Manufacturer) :
Arkis BioSciences Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SureFlo EVD Catheter is indicated for temporary insertion into a ventricular cavity of the brain for external drainage of cerebrospinal fluid (CSF) in those patients with elevated intracranial pressure (ICP), intraventricular hemorrhage, or hydrocephalic shunt infections.
Device Description
The SureFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through drainage holes near the catheter's bullet shaped tip. Similar to the predicate, the catheter is barium- sulfate- impregnated to provide radiopacity. Black stripes are located every 1 cm between 5 cm and 15 cm from the catheter tip to assist the surgeon in catheter placement. Double stripes and numerical markings are located at 10 cm and 15 cm. (All dimensions are nominal).
The SureFlo EVD Catheter is provided with a stainless steel Stylette, stainless steel Trocar, Barbed Luer Connecter, Male Luer Cap and silicone Suture Clip. The stainless-steel Stylet facilitates catheter placement for introduction of the catheter into the ventricle or other ventricular target site. A Trocar is supplied with the catheter to facilitate subcutaneous tunneling away from the burr hole. The external portion of the catheter may be secured to the scalp by the radiopaque Suture Clip. The Barbed Luer Connector supplied with each SureFlo EVD Catheter will connect the catheter to external drainage systems. The included Male Luer Cap may be used to close (cap) the barbed luer connector until the catheter is connected to a drainage or monitoring device.
The SureFlo EVD Catheter and its accessories are provided sterile.
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