FLEXIBLE INTRACARDIAC SUCTION DEVICE
Device Facts
| Record ID | K905008 |
|---|---|
| Device Name | FLEXIBLE INTRACARDIAC SUCTION DEVICE |
| Applicant | Gish Biomedical, Inc. |
| Product Code | DTS · Cardiovascular |
| Decision Date | Jan 23, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4420 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
