Code of Federal Regulations · Section

§ 870.3935 — Prosthetic Heart Valve Holder

21 C.F.R. § 870.3935

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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.

21 C.F.R. § 870.3925 21 C.F.R. § 870.3945

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