COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B— 510(k) K051912

Unknown

Alsius Corp.

FDA 510(k) clearance K051912 for COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B, Unknown on 2005-10-11. Applicant: Alsius Corp..

Clearance details

Applicant: Alsius Corp.
Product code: Code NCX
Advisory panel: Cardiovascular
Date received: 2005-07-14
Decision date: 2005-10-11
Decision: Unknown
Clearance type: Traditional
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.