§ 870.1330 - Catheter guide wire.  


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  • § 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 (performance standards). 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]