§870.3935. Prosthetic heart valve holder.
21 C.F.R. § 870.3935
Identification. A prosthetic heart valve holder is a device used to hold a replacement heart valve while it is being sutured into place.
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
Notes, amendments, and revision history
Amendments
[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.
Amendments
[45 FR 7907, Feb. 5, 1980, as amended at 61 FR 1121, Jan. 16, 1996]