21 CFR 870.4075 — Device, Biopsy, Endomyocardial
Cardiovascular (CV) · Part 870 Subpart E—Cardiovascular Surgical Devices · § 870.4075
Identification
An endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DWZ | Device, Biopsy, Endomyocardial | 2 | 23 | 3rd Party |
| MFY | Endothelial Cell Harvesting Kit | 2 | 1 | |
| OFG | Ct Biopsy Tray | 2 | 0 |
