DeviceClearance

Product code MJN— Cardiovascular

RenovoCath

Classification name
Catheter, Intravascular Occluding, Temporary
Device class
Class 2
Regulation
21 CFR 870.4450
Advisory panel
Cardiovascular
Total cleared
90
First cleared
Most recent

Market context for product code MJN

FDA has cleared 90 devices under product code MJN between 1992 and 2025, filed by 45 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

last 15 years

Top applicants under product code MJN

Adverse events under product code MJN

product code MJN
Death
31
Injury
240
Malfunction
827
Total
1,098

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code MJN

Data sourced from openFDA. This site is unofficial and independent of the FDA.