DeviceClearance

Product code MAV— Cardiovascular

ENCORE 26 ADVANTAGE KIT

Classification name
Syringe, Balloon Inflation
Device class
Class 2
Regulation
21 CFR 870.1650
Advisory panel
Cardiovascular
Total cleared
58
First cleared
Most recent

Market context for product code MAV

FDA has cleared 58 devices under product code MAV between 1981 and 2026, filed by 41 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 MAV

Adverse events under product code MAV

product code MAV
Malfunction
1,433
Total
1,433

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 MAV

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