ARCTIC BLAST INTRAVENOUS FLUID CHILLER— 510(k) K080899

Substantially Equivalent

Medivance, Inc.

FDA 510(k) clearance K080899 for ARCTIC BLAST INTRAVENOUS FLUID CHILLER, Substantially Equivalent on 2008-08-07. Applicant: Medivance, Inc..

Clearance details

Applicant: Medivance, Inc.
Product code: Code NCX
Advisory panel: Cardiovascular
Date received: 2008-03-31
Decision date: 2008-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, CO, 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.