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e-CFR data is current as of January 14, 2021

Title 21Chapter ISubchapter HPart 870Subpart D → §870.3935


Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart D—Cardiovascular Prosthetic Devices


§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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