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The VasoQuential is designed to increase venous blood flow in at The Vasoquencear in order to help prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

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The provided text is an FDA 510(k) clearance letter for the VasoQuential Model VQ530, a compressible limb sleeve designed to increase venous blood flow and prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

It states that the device has been found substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about the acceptance criteria, specific studies, sample sizes, expert qualifications, or ground truth establishment that would be required to answer your detailed questions.

Regulatory clearance letters typically confirm that a device meets the substantial equivalence criteria based on information submitted in a 510(k) premarket notification. The detailed performance data, acceptance criteria, and study designs are part of the submission itself, not usually included in the clearance letter.

Therefore, I cannot provide the requested information from the given text. To answer your questions, I would need access to the actual 510(k) premarket notification document or related performance study reports for the VasoQuential Model VQ530.

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