SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM— 510(k) K012512

Clearance details

Applicant

Radiant Medical

Product code

Code NCX

Device class

Class 2

Regulation

21 CFR 870.5900

Advisory panel

Cardiovascular

Date received

2001-08-06

Decision date

2002-06-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Redwood City, CA, US

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• K220008 — Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console2022-06-02
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• K152946 — TEMPEDY2016-09-15
• K153162 — Hypocore2016-05-24

• 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
• K024327 — SETPOINT ENDOVASCULAR TEMPERATURE PROBE2003-03-25

Death

30

Malfunction

2,302

Total

2,332

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 →