MODIFIED RLV-2100 B
Device Facts
| Record ID | K864503 |
|---|---|
| Device Name | MODIFIED RLV-2100 B |
| Applicant | American Omni Medical, Inc. |
| Product Code | DWD · Cardiovascular |
| Decision Date | Jan 6, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4430 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cardiopulmonary bypass intracardiac suction control is a device which provides the vacuum and control for a cardiotomy return sucker.
Special Controls
*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.
