---
kind: "section"
citation: "21 C.F.R. § 870.3945"
title: "21"
number: "870.3945"
heading: "Prosthetic heart valve sizer."
url: "https://uscodex.org/cfr/21/870.3945"
---

# §870.3945. Prosthetic heart valve sizer.

- (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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 870.9](/cfr/21/870.9.md).

## Notes

### Amendments

[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38797, July 25, 2001]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.

### Amendments

[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38797, July 25, 2001]