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The Primary I.V. Set with Backcheck Valve is used for the delivery of I.V. fluids through the primary line or through the attachment of a secondary line into the backcheck valve. A backcheck valve prevents the intermixing of fluids while the secondary line is running. Then, when the secondary line is emptied, the valve automatically restores flow from the primary container.

Primary I.V. Set with Backcheck Valve

This document is a 510(k) clearance letter from the FDA for a medical device called "Primary I.V. Set with Backcheck Valve." It does not contain information on acceptance criteria, device performance, an associated study, or any of the other specific details requested in the prompt (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information).

The letter simply states that the FDA has reviewed the manufacturer's notification and determined that the device is substantially equivalent to legally marketed predicate devices. It then outlines the regulatory framework and responsibilities for the manufacturer.

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