510(k) K092451— INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER

Substantially Equivalent

Intersurgical, Inc.

Clearance details

Applicant: Intersurgical, Inc.
Product code: Code CAH
Advisory panel: Anesthesiology
Date received: 2009-08-10
Decision date: 2010-10-29
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.