DeviceClearance

Product code DWA— Cardiovascular

Anivia SG1000 Pump Console

Classification name
Control, Pump Speed, Cardiopulmonary Bypass
Device class
Class 2
Regulation
21 CFR 870.4380
Advisory panel
Cardiovascular
Total cleared
37
First cleared
Most recent

Market context for product code DWA

FDA has cleared 37 devices under product code DWA between 1978 and 2024, filed by 19 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 DWA

Adverse events under product code DWA

product code DWA
Death
15
Malfunction
1,654
Total
1,669

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 DWA

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