HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER— 510(k) K092409

Substantially Equivalent

Intersurgical, Inc.

FDA 510(k) clearance K092409 for HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER, Substantially Equivalent on 2010-03-10. Applicant: Intersurgical, Inc..

Clearance details

Applicant: Intersurgical, Inc.
Product code: Code CAH
Advisory panel: Anesthesiology
Date received: 2009-08-06
Decision date: 2010-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Liverpool, NY, US

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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.