DeviceClearance

Product code DTQ— Cardiovascular

Advanced Perfusion System 1

Classification name
Console, Heart-Lung Machine, Cardiopulmonary Bypass
Device class
Class 2
Regulation
21 CFR 870.4220
Advisory panel
Cardiovascular
Total cleared
52
First cleared
Most recent

Market context for product code DTQ

FDA has cleared 52 devices under product code DTQ between 1977 and 2023, 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 DTQ

Adverse events under product code DTQ

product code DTQ
Death
123
Malfunction
4,822
Other
1
Total
4,946

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 DTQ

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