21 CFR 870.3935 — Holder, Heart-Valve, Prosthesis
Cardiovascular (CV) · Part 870 Subpart D—Cardiovascular Prosthetic Devices · § 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 Rationale
Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DTJ | Holder, Heart-Valve, Prosthesis | 1 | 12 | |
| MOP | Rotator, Prosthetic Heart Valve | 1 | 4 |
