21 CFR 870.4420 — Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Cardiovascular (CV) · Part 870 Subpart E—Cardiovascular Surgical Devices · § 870.4420
Identification
A cardiopulmonary bypass cardiotomy return sucker is a device that consists of tubing, a connector, and a probe or tip that is used to remove blood from the chest or heart during cardiopulmonary bypass surgery.
Classification Rationale
Class II (special 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 |
|---|---|---|---|---|
| DTS | Sucker, Cardiotomy Return, Cardiopulmonary Bypass | 2 | 9 |
Special Controls
DTS — Sucker, Cardiotomy Return, Cardiopulmonary Bypass
*Classification.* Class II (special 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.
eCFR
