THERMOFLO HCH, THERMOFLO FILTER— 510(k) K090738

Substantially Equivalent

Arc Medical, Inc.

FDA 510(k) clearance K090738 for THERMOFLO HCH, THERMOFLO FILTER, Substantially Equivalent on 2009-07-27. Applicant: Arc Medical, Inc..

Clearance details

Applicant: Arc Medical, Inc.
Product code: Code CAH
Advisory panel: Anesthesiology
Date received: 2009-03-20
Decision date: 2009-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

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.