Evaluation summary: the device was returned in the original packaging.The information reported on the compliance chart are not consistent with the product specifications (as indicated in the label applied on the box and pouch and as marked on the hub).The compliance chart wrongly refers to a balloon diameter of 6 mm, instead of 5 mm.A visual and a tactile analysis was carried out on the relevant device, no abnormalities were detected on the device itself.Finally, the balloon diameter was measured at the nominal pressure: the balloon diameter was 5 mm, confirming that the compliance chart does not correspond to the actual balloon size.(b)(4).
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