21 CFR 870.4500 — Instruments, Surgical, Cardiovascular
Cardiovascular (CV) · Part 870 Subpart E—Cardiovascular Surgical Devices · § 870.4500
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DWS | Instruments, Surgical, Cardiovascular | 1 | 71 | |
| LXN | Probe, Test, Heart-Valve | 1 | 2 | |
| MWS | Stabilizer, Heart | 1 | 4 | |
| NQG | Stabilizer, Heart, Non-Compression, Reprocessed | 1 | 3 | 3rd Party |
| OFA | Cardiovascular Surgical Instruments Tray | 1 | 0 |
