K121026

Substantially Equivalent

FLO-GUARD BREATHING FILTER

Applicant: Intersurgical, Inc.
Product code: CAH
Advisory panel: Anesthesiology
Date received: 2012-04-04
Decision date: 2012-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Liverpool, NY, US

Adverse events under product code CAH

product code CAH

Death: 7
Total: 7

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.