OFG · Ct Biopsy Tray
Cardiovascular · 21 CFR 870.4075 · Class 2
Overview
| Product Code | OFG |
|---|---|
| Device Name | Ct Biopsy Tray |
| Regulation | 21 CFR 870.4075 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
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).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
