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Medical Devices / Submissions and Approvals

FDA Clears RMS Medical’s Subcutaneous Needle Set

April 22, 2019
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The FDA granted RMS Medical 510(k) clearance for its High-Flo Super26 subcutaneous needle set, a device indicated for subcutaneous infusion of medications in various settings.

The high flow-rate device, offered in packs ranging from one to six needles, is designed for use at home, in the hospital or in the ambulance.

The device uses a small diameter needle, which could increase patient comfort during large volume drug infusions, the company says.

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