StacksVerified U.S. regulatory reference

21 CFR §870.4075

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. An endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart.
  2. (b)Classification. Class II (performance standards).