---
kind: "section"
citation: "21 C.F.R. § 870.3935"
title: "21"
number: "870.3935"
heading: "Prosthetic heart valve holder."
url: "https://uscodex.org/cfr/21/870.3935"
---

# §870.3935. Prosthetic heart valve holder.

- (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](/cfr/21/part807-subpartE.md) of this chapter.

## Notes

### Amendments

[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996]

### 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]