DeviceClearance

Product code MCW— Cardiovascular

Auryon Atherectomy System

Classification name
Catheter, Peripheral, Atherectomy
Device class
Class 2
Regulation
21 CFR 870.4875
Advisory panel
Cardiovascular
Total cleared
146
First cleared
Most recent

Market context for product code MCW

FDA has cleared 146 devices under product code MCW between 1990 and 2026, filed by 49 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 MCW

Adverse events under product code MCW

product code MCW
Death
38
Injury
1,386
Malfunction
2,676
Other
2
Total
4,102

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 MCW

1–100 of 146

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