DeviceClearance

Product code DWC— Cardiovascular

Heater-Cooler System 3T

Classification name
Controller, Temperature, Cardiopulmonary Bypass
Device class
Class 2
Regulation
21 CFR 870.4250
Advisory panel
Cardiovascular
Total cleared
30
First cleared
Most recent

FDA classification definition

“If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).”

— U.S. Food and Drug Administration, device classification record for product code DWC under 21 CFR 870.4250, via openFDA

Market context for product code DWC

FDA has cleared 30 devices under product code DWC between 1981 and 2022, filed by 22 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 DWC

Adverse events under product code DWC

product code DWC
Death
124
Injury
233
Malfunction
3,727
Total
4,084

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 DWC

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