21 CFR § 870.1270 Cardiovascular Devices

§ 870.1270 Intracavitary phonocatheter system.

Current through Sep 8, 2026 · Read all of Part 870

⚠ 3 pending changes to Part 870

(a) Identification. An intracavitary phonocatheter system is a system that includes a catheter with an acoustic transducer and the associated device that processes the signal from the transducer; this device records bioacoustic phenomena from a transducer placed within the heart, blood vessels, or body cavities.

(b) Classification. Class II (performance standards).

← § 870.1255 Balloon aortic valvuloplasty catheter.§ 870.1280 Steerable catheter. →