21 CFR 870.3945
§ 870.3945 Prosthetic heart valve sizer.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 870.3945, § 870.3945 Prosthetic heart valve sizer, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89982
- Permanent ID
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Full text
(a) Identification. A prosthetic heart valve sizer is a device used to measure the size of the natural valve opening to determine the size of the appropriate replacement heart valve.
(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 § 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.