DeviceClearance

Product code DTR— Cardiovascular

MYOCARDIAL PROTECTION SYSTEM

Classification name
Heat-Exchanger, Cardiopulmonary Bypass
Device class
Class 2
Regulation
21 CFR 870.4240
Advisory panel
Cardiovascular
Total cleared
91
First cleared
Most recent

Market context for product code DTR

FDA has cleared 91 devices under product code DTR between 1977 and 2026, filed by 41 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 DTR

Adverse events under product code DTR

product code DTR
Other
1
Total
1

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 DTR

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