Title 21

SECTION 870.1330

870.1330 Catheter guide wire.

§ 870.1330 Catheter guide wire.

(a) Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

(b) Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, 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]