K252643
- 510(k) number
- K252643
- Device name
- Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled
- Applicant
- Teleflex Medical Sdn. Bhd. MY
- Product code
- CAH — Filter, Bacterial, Breathing-Circuit
- Decision date
- 2026-05-15
- Date received
- 2025-08-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K252643.pdf
Official FDA record: K252643
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.