eCFR Reference Browser

---

title: "21 CFR §870.5150"

source: "https://www.ecfr.gov/current/title-21/section-870.5150"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "870"

part_subject: "CARDIOVASCULAR DEVICES"

subpart_code: "F"

subpart_subject: "Cardiovascular Therapeutic Devices"

section_number: "870.5150"

section_subject: "Embolectomy catheter."

cfr_reference: "21 CFR 870.5150"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

(b)Classification. Class II (performance standards).

§870.5150 - Embolectomy catheter.