21 CFR 870.1330
§ 870.1330 Catheter guide wire.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 870.1330, § 870.1330 Catheter guide wire, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89888
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.