510(k) K210603— 3M Bair Hugger Temperature Management System (Model 675)

Substantially Equivalent

3M Company

Clearance details

Applicant: 3M Company
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 2021-03-01
Decision date: 2021-03-30
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Paul, MN, US

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.