ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM— 510(k) K030421

Clearance details

Applicant

Alsius Corp.

Product code

Code NCX

Device class

Class 2

Regulation

21 CFR 870.5900

Advisory panel

Cardiovascular

Date received

2003-02-10

Decision date

2003-10-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Irvine, CA, US

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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 →