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Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 870.1340: Catheter introducer.

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Where this section sits in the code
  1. Title 21—Food and Drugs
  2. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  3. SUBCHAPTER H—MEDICAL DEVICES
  4. PART 870—CARDIOVASCULAR DEVICES
  5. Subpart B—Cardiovascular Diagnostic Devices

(a) Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

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

Collected 2026-08-27T02:24:47Z. Source file · JSON

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