MJJ · Cpb Check Valve, Retrograde Flow, In-Line
Cardiovascular · 21 CFR 870.4400 · Class 2
Overview
| Product Code | MJJ |
|---|---|
| Device Name | Cpb Check Valve, Retrograde Flow, In-Line |
| Regulation | 21 CFR 870.4400 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
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 (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K182442 | MiniGuard Arterial Safety Valve | Quest Medical, Inc. | Nov 6, 2018 | SESE |
| K142500 | One Way Soft Valve | Terumo Cardiovascular Systems Corporation | Jan 29, 2015 | SESE |
| K001245 | 3T L. V. CONTROL VALVE | 3t Medical Systems, LLC | Aug 15, 2001 | SESE |
| K992785 | IBC FLOGUARD, MODEL 6050 | International Biophysics Corp. | Jan 14, 2000 | SESE |
| K982406 | COBE VACUUM RELIEF CHECK VALVE | Cobe Cardiovascular, Inc. | Oct 7, 1998 | SESE |
| K960937 | SUCTION SAFETY DEVICE | R D Intl. | Jun 5, 1996 | SESE |
| K922781 | FLOW CONROL VALVE | American Omni Medical, Inc. | Mar 8, 1993 | SESE |
| K922356 | FLOW CONTROL VALVE, CAT. NO. ACV-38 | American Omni Medical, Inc. | Feb 12, 1993 | SESE |
| K921500 | CENTRI-SAFE(TM) VALVE | Cardio Systems, Inc. | Sep 15, 1992 | SESE |
Top Applicants
- American Omni Medical, Inc. — 2 clearances
- 3t Medical Systems, LLC — 1 clearance
- Cardio Systems, Inc. — 1 clearance
- Cobe Cardiovascular, Inc. — 1 clearance
- International Biophysics Corp. — 1 clearance
