510(k) K252643— Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled

Substantially Equivalent

Teleflex Medical Sdn. Bhd.

Clearance details

Applicant: Teleflex Medical Sdn. Bhd.
Product code: Code CAH
Advisory panel: Anesthesiology
Date received: 2025-08-21
Decision date: 2026-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kamunting, MY

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.