21 CFR 870.4340 — Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Cardiovascular (CV) · Part 870 Subpart E—Cardiovascular Surgical Devices · § 870.4340
Identification
A cardiopulmonary bypass level sensing monitor and/or control is a device used to monitor and/or control the level of blood in the blood reservoir and to sound an alarm when the level falls below a predetermined value.
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 |
|---|---|---|---|---|
| DTW | Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass | 2 | 17 |
Special Controls
DTW — Monitor And/Or Control, Level Sensing, 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
