1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 870 - CARDIOVASCULAR DEVICES
  6. Subpart F - Cardiovascular Therapeutic Devices
  7. 21 CFR § 870.5175
21 CFR § 870.5175
Septostomy catheter
June 25, 2020
CFR

(a) Identification. A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.

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

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§ 870.5150 Embolectomy catheter
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§ 870.5200 External cardiac compressor

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