SETPOINT ENDOVASCULAR TEMPERATURE PROBE— 510(k) K024327

Substantially Equivalent

Radiant Medical

FDA 510(k) clearance K024327 for SETPOINT ENDOVASCULAR TEMPERATURE PROBE, Substantially Equivalent on 2003-03-25. Applicant: Radiant Medical.

Clearance details

Applicant: Radiant Medical
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2002-12-26
Decision date: 2003-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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