21 CFR 870.3935

§ 870.3935 Prosthetic heart valve holder.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 870.3935, § 870.3935 Prosthetic heart valve holder, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89981
Permanent ID: ys:prov:89981@1
SHA-256: 5fe9656d935cfda7b8e5885ee18445c5609aa92124669d01358efbfb356df2bc

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Full text

(a) Identification. A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.