FDA 510(k)

Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled

Número K: K252643 · 2026-05-15

Data da decisão2026-05-15

Código do produtoCAH

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical Sdn. Bhd.. It received FDA 510(k) clearance on 2026-05-15 under 510(k) number K252643. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled?

Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled is a medical device that received FDA 510(k) clearance on 2026-05-15. The listed applicant is Teleflex Medical Sdn. Bhd.. The 510(k) number is K252643.

When did Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled receive FDA 510(k) clearance?

Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled received FDA 510(k) clearance on 2026-05-15, under 510(k) number K252643.

Who is the listed applicant for Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled?

The FDA 510(k) record lists Teleflex Medical Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled?

The FDA product code for Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled is CAH.

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Fonte oficial

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