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Use for temporary cannulation for vascular access for extracorporeal blood treatment. The device is intended for single use only and is for temporary catheterization of less than 30 days. The device has an anti-stick feature integrated as part of the Needle Set which aids in prevention of needle-stick injuries when withdrawing and discarding the needle after treatment.

JMS SysLoc A.V. Fistula Needle Set and JMS SysLoc Apheresis Needle Set

This document is a 510(k) clearance letter from the FDA for the JMS SysLoc A.V. Fistula Needle Set and JMS SysLoc Apheresis Needle Set. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this letter does NOT contain acceptance criteria for device performance or the results of studies proving the device meets said criteria. The FDA 510(k) clearance process focuses on substantial equivalence to existing devices rather than requiring new clinical trials to establish safety and effectiveness for every submission.

Therefore, I cannot provide the requested information from the provided text. The document is primarily a regulatory approval notice, not a detailed technical report on device performance.

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