This page lists all FDA 510(k) submissions for Heat-exchanger, Cardiopulmonary Bypass devices (product code DTR). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →

Data Source

FDA 510(k) public files . 4,872 total devices indexed.

Latest clearance: May 30, 2025

Product Code Info

Code	DTR
Device class	Class II
CFR	21 CFR 870.4240
Panel	Cardiovascular

Verify on FDA.gov

View DTR classification on FDA.gov →