SETPOINT ENDOVASCULAR TEMPERATURE PROBE— 510(k) K024327

Name: FDA 510(k) clearance K024327
Creator: U.S. Food and Drug Administration
Published: 2003-03-25

Substantially Equivalent

Radiant Medical

FDA 510(k) clearance K024327 for SETPOINT ENDOVASCULAR TEMPERATURE PROBE, Substantially Equivalent on 2003-03-25. Applicant: Radiant Medical. Device class: 2.

Clearance details

Applicant: Radiant Medical
Product code: Code DQY
Device class: Class 2
Regulation: 21 CFR 870.1250
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 ↗

Recent devices under product code DQY

view all

K260559 — NHanceIT2026-08-14
K262392 — APRO 35 Swift Catheter2026-08-12
K261766 — CPS Locator 3D Plus Delivery Catheter2026-07-29
K262240 — SSPC NXT Delivery Catheter2026-07-29
K261825 — Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter2026-07-02

More clearances from Radiant Medical

view all

K071358 — REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM2007-06-01
K071008 — REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM2007-05-09
K063405 — REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM2007-01-08
K042388 — RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE2004-10-28
K012512 — SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM2002-06-11

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.