21 CFR § 870.1390 Cardiovascular Devices

§ 870.1390 Trocar.

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

⚠ 3 pending changes to Part 870

(a) Identification. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.

(b) Classification. Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71811, Dec. 30, 2019]

← § 870.1380 Catheter stylet.§ 870.1405 Interventional cardiovascular implant simulation software device. →