MNJ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Valve, Pressure Relief, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4400
- Medical specialty
- Cardiovascular
- Adverse events (MAUDE)
- 2001: 4 · 2003: 4 · 2004: 3 · 2005: 3 · 2006: 4 · 2009: 3
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 |
|---|---|---|
| IBC VENT VALVE, MODEL 1400 (K992964) | International Biophysics Corp. | 1999-11-19 |
| PRESSURE RELIEF VALVE (K941492) | Circulatory Technology, Inc. | 1994-10-26 |
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Every clearance here is in the API, with alerts when new ones post.