21 C.F.R. § 870.1330

Current through October 31, 2024
Section 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 .

21 C.F.R. §870.1330

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