MJJ
9 FDA 510(k) clearances · Product code
148 daysmedian time to decision
484 days90th percentile
9clearances measured
FDA profile
- Official device name
- Cpb Check Valve, Retrograde Flow, In-Line
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4400
- Medical specialty
- Cardiovascular
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1993: 1 · 2006: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MiniGuard Arterial Safety Valve (K182442) | Quest Medical, Inc. | 2018-11-06 |
| One Way Soft Valve (K142500) | Terumo Cardiovascular Systems Corporation | 2015-01-29 |
| 3T L. V. CONTROL VALVE (K001245) | 3t Medical Systems, LLC | 2001-08-15 |
| IBC FLOGUARD, MODEL 6050 (K992785) | International Biophysics Corp. | 2000-01-14 |
| COBE VACUUM RELIEF CHECK VALVE (K982406) | Cobe Cardiovascular, Inc. | 1998-10-07 |
| SUCTION SAFETY DEVICE (K960937) | R D Intl. | 1996-06-05 |
| FLOW CONROL VALVE (K922781) | American Omni Medical, Inc. | 1993-03-08 |
| FLOW CONTROL VALVE, CAT. NO. ACV-38 (K922356) | American Omni Medical, Inc. | 1993-02-12 |
| CENTRI-SAFE(TM) VALVE (K921500) | Cardio Systems, Inc. | 1992-09-15 |
Track MJJ automatically
Every clearance here is in the API, with alerts when new ones post.