Diagnostic intravascular catheter.

21 C.F.R. § 870.1200
in effectEffective: 2024-07-01
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(a) Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others. (b) Classification. Class II (performance standards).

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