21 CFR 882.4545
§ 882.4545 Shunt system implantation instrument.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 882.4545, § 882.4545 Shunt system implantation instrument, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90700
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Full text
(a) Identification. A shunt system implantation instrument is an instrument used in the implantation of cerebrospinal fluid shunts, and includes tunneling instruments for passing shunt components under the skin.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.