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FDA 510(k)

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

K-Number: K252643 · 2026-05-15

ApplicantTeleflex Medical Sdn. Bhd.
Decision Date2026-05-15
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Teleflex Medical Sdn. Bhd. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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