K101705

Substantially Equivalent

MISTRAL-AIR WARMING SYSTEM

Applicant: The Surgical Company International B.V.
Product code: DWJ
Advisory panel: Cardiovascular
Date received: 2010-06-17
Decision date: 2010-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beeldschermweg 6g, NL

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.