510(k) K102618— VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED

Substantially Equivalent

Draeger Medical AG & Co. KG

Clearance details

Applicant: Draeger Medical AG & Co. KG
Product code: Code BTT
Advisory panel: Anesthesiology
Date received: 2010-09-13
Decision date: 2010-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Telford, PA, US

Adverse events under product code BTT

product code BTT

Death: 60
Injury: 152
Malfunction: 7,232
Other: 2
Total: 7,446

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.