OFA · Cardiovascular Surgical Instruments Tray
Cardiovascular · 21 CFR 870.4500 · Class 1
Overview
| Product Code | OFA |
|---|---|
| Device Name | Cardiovascular Surgical Instruments Tray |
| Regulation | 21 CFR 870.4500 |
| Device Class | Class 1 |
| Review Panel | Cardiovascular |
Identification
Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
