21 CFR § 870.4075 - Endomyocardial biopsy device.
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§ 870.4075 Endomyocardial biopsy device.
(a) Identification. An endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart.
(b) Classification. Class II (performance standards).