Arctic Sun Temperature Management System (Model 5000)— 510(k) K251974

Substantially Equivalent

Medivance, Inc.

FDA 510(k) clearance K251974 for Arctic Sun Temperature Management System (Model 5000), Substantially Equivalent on 2025-10-24. Applicant: Medivance, Inc..

Clearance details

Applicant: Medivance, Inc.
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 2025-06-26
Decision date: 2025-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DWJ

product code DWJ

Death: 7
Injury: 679
Malfunction: 17,477
Total: 18,163

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.