StacksVerified U.S. regulatory reference

21 CFR §870.5150

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (a)Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.
  2. (b)Classification. Class II (performance standards).