Prosthetic heart valve holder.

21 C.F.R. § 870.3935
in effectEffective: 2024-07-01
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(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.

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