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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 a medical device manufactured by Teleflex Medical Sdn. Bhd.. It received FDA 510(k) clearance on 2026-05-15 under approval 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. It is manufactured by Teleflex Medical Sdn. Bhd.. The 510(k) number is K252643.

When was Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled approved by the FDA?

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

What company makes Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled?

Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled is manufactured by Teleflex Medical Sdn. Bhd..

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.

Related Devices (Code: CAH)

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Official Source

View on FDA Database →

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

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