HepaShield Bacterial Viral Breathing System Filter— 510(k) K191909

Substantially Equivalent

Flexicare Medical Limited.

FDA 510(k) clearance K191909 for HepaShield Bacterial Viral Breathing System Filter, Substantially Equivalent on 2020-03-23. Applicant: Flexicare Medical Limited..

Clearance details

Applicant: Flexicare Medical Limited.
Product code: Code CAH
Advisory panel: Anesthesiology
Date received: 2019-07-17
Decision date: 2020-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain Ash, GB

Download summary PDF View on FDA.gov ↗

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.