Prosthetic heart valve holder.

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Cardiovascular Devices
  7. Cardiovascular Prosthetic Devices
  8. Prosthetic heart valve holder.

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§ 870.3935 Prosthetic heart valve holder.

(a) Identification. A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996]


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