MNJ — Valve, Pressure Relief, Cardiopulmonary Bypass Class II

FDA Device Classification

FDA product code MNJ covers "Valve, Pressure Relief, Cardiopulmonary Bypass", a Class II medical device regulated under 21 CFR 870.4400. Submissions are reviewed by the Cardiovascular panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MNJ
Device Class
Class II
Regulation Number
870.4400
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K992964international biophysicsIBC VENT VALVE, MODEL 1400November 19, 1999
K941492circulatory technologyPRESSURE RELIEF VALVEOctober 26, 1994