FDA product code MNJ: Valve, Pressure Relief, Cardiopulmonary Bypass
MNJ is the FDA product code for valve, pressure relief, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4400 and reviewed by the Cardiovascular panel. FDA has cleared 2 510(k) submissions under MNJ, from 2 different applicants. The average 510(k) review took 145 days (median 145). FDA has posted 1 recall for MNJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Valve, Pressure Relief, Cardiopulmonary Bypass |
| Device class | Class II |
| Regulation | 21 CFR 870.4400 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every MNJ clearance
Top MNJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| International Biophysics Corp. | 1 | 1999-11-19 |
| Circulatory Technology, Inc. | 1 | 1994-10-26 |
Most recent MNJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K992964 | International Biophysics Corp. | IBC VENT VALVE, MODEL 1400 | 1999-11-19 | 78 |
| K941492 | Circulatory Technology, Inc. | PRESSURE RELIEF VALVE | 1994-10-26 | 212 |
Recalls for MNJ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-06-04.
Frequently asked questions
What is FDA product code MNJ?
MNJ is the FDA product code for valve, pressure relief, cardiopulmonary bypass. It is a Class II device, regulated under 21 CFR 870.4400 and reviewed by the Cardiovascular panel.
What device class is MNJ?
Class II, regulation 21 CFR 870.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code MNJ?
Across 2 cleared submissions the average was 145 days from receipt to decision (median 145).
Which companies have the most MNJ clearances?
International Biophysics Corp. (1); Circulatory Technology, Inc. (1).
Have MNJ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-06-04.
Next steps
- Run an FDA pathway report with predicate devices for product code MNJ
- Run a recall and safety report across every MNJ manufacturer
- Watch product code MNJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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