Product code MNJ— Cardiovascular
IBC VENT VALVE, MODEL 1400
- Classification name
- Valve, Pressure Relief, Cardiopulmonary Bypass
- Device class
- Class 2
- Regulation
- 21 CFR 870.4400
- Advisory panel
- Cardiovascular
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code MNJ
FDA has cleared devices under product code MNJ between 1994 and 1999, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1999
- 1994
Top applicants under product code MNJ
Recent clearances under product code MNJ
Data sourced from openFDA. This site is unofficial and independent of the FDA.