MNJ · Valve, Pressure Relief, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4400 · Class 2
Overview
| Product Code | MNJ |
|---|---|
| Device Name | Valve, Pressure Relief, Cardiopulmonary Bypass |
| Regulation | 21 CFR 870.4400 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.
Classification Rationale
Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Special Controls
*Classification.* Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K992964 | IBC VENT VALVE, MODEL 1400 | International Biophysics Corp. | Nov 19, 1999 | SESE |
| K941492 | PRESSURE RELIEF VALVE | Circulatory Technology, Inc. | Oct 26, 1994 | SESE |
Top Applicants
- International Biophysics Corp. — 1 clearance
- Circulatory Technology, Inc. — 1 clearance
