510(k) K171234— Mistral-Air Warming Unit

Substantially Equivalent

The Surgical Company International BV (As the 37company)

Clearance details

Applicant: The Surgical Company International BV (As the 37company)
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 2017-04-27
Decision date: 2017-05-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Amersfoort, 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.