DeviceClearance

Product code DXE— Cardiovascular

ARTERIAL EMBOLECTOMY CATHETER

Classification name
Catheter, Embolectomy
Device class
Class 2
Regulation
21 CFR 870.5150
Advisory panel
Cardiovascular
Total cleared
74
First cleared
Most recent

Market context for product code DXE

FDA has cleared 74 devices under product code DXE between 1976 and 2024, 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 DXE

Adverse events under product code DXE

product code DXE
Death
27
Injury
258
Malfunction
2,266
Total
2,551

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 DXE

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