DeviceClearance

Product code DTX— Cardiovascular

Quantum Ventilation Module

Classification name
Gas Control Unit, Cardiopulmonary Bypass
Device class
Class 2
Regulation
21 CFR 870.4300
Advisory panel
Cardiovascular
Total cleared
10
First cleared
Most recent

Market context for product code DTX

FDA has cleared 10 devices under product code DTX between 1979 and 2021, filed by 8 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

Top applicants under product code DTX

Adverse events under product code DTX

product code DTX
Death
3
Malfunction
497
Total
500

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 DTX

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