VORTRAN GO2VENT— 510(k) K162968

Substantially Equivalent

Vortran Medical Technology 1, Inc.

FDA 510(k) clearance K162968 for VORTRAN GO2VENT, Substantially Equivalent on 2017-04-10. Applicant: Vortran Medical Technology 1, Inc..

Clearance details

Applicant: Vortran Medical Technology 1, Inc.
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 2016-10-24
Decision date: 2017-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sacramento, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BTL

product code BTL

Death: 8
Malfunction: 3,256
Other: 1
Total: 3,265

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.