StacksVerified U.S. regulatory reference

21 CFR §870.3935

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place.
  2. (b)Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.