DeviceClearance

Product code DWE— Cardiovascular

AngioVac Circuit

Classification name
Tubing, Pump, Cardiopulmonary Bypass
Device class
Class 2
Regulation
21 CFR 870.4390
Advisory panel
Cardiovascular
Total cleared
21
First cleared
Most recent

Market context for product code DWE

FDA has cleared 21 devices under product code DWE between 1980 and 2024, filed by 18 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 DWE

Adverse events under product code DWE

product code DWE
Death
9
Malfunction
754
Total
763

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 DWE

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