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 D - Cardiovascular Prosthetic Devices
  7. 21 CFR § 870.3470
21 CFR § 870.3470
Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene
June 25, 2020
CFR

(a) Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.

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

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§ 870.3460 Endovascular Suturing System
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§ 870.3535 Intra-aortic balloon and control system

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