FDA Product Code MJN: Catheter, Intravascular Occluding, Temporary
Leading manufacturers include Edwards Lifesciences, LLC, Abiomed, Inc. and Prytime Medical Devices, Inc..
FDA 510(k) Cleared Catheter, Intravascular Occluding, Temporary Devices (Product Code MJN)
About Product Code MJN - Regulatory Context
510(k) Submission Activity
90 total 510(k) submissions under product code MJN since 1992, with 90 receiving FDA clearance (average review time: 133 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under MJN have taken an average of 162 days to reach a decision - up from 133 days historically. Manufacturers should account for longer review timelines in current project planning.
MJN devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →