THERMOGARD THERMAL REGULATION SYSTEM— 510(k) K063829

Unknown

Alsius Corp.

FDA 510(k) clearance K063829 for THERMOGARD THERMAL REGULATION SYSTEM, Unknown on 2007-01-22. Applicant: Alsius Corp..

Clearance details

Applicant: Alsius Corp.
Product code: Code NCX
Advisory panel: Cardiovascular
Date received: 2006-12-26
Decision date: 2007-01-22
Decision: Unknown
Clearance type: Special
Location: Irvine, CA, US

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Adverse events under product code NCX

product code NCX

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 →

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