(44 days)
This device is intended for use in MR imaging of peripheral blood yessels in the lower extremity for patients with suspected peripheral vascular disease for diagnostic purposes and pre-operative information.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.
The letter states that the device, an "MRI Compatible Thigh Tourniquet," has been determined to be substantially equivalent to legally marketed predicate devices. This determination is based on the indications for use provided by the applicant.
Therefore, I cannot extract the requested information as it is not present in the provided document.
§ 878.5910 Pneumatic tourniquet.
(a)
Identification. A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.