FDA 510(k)

Iso-Gard過濾直管；濕氣通風過濾器小型斜角

K 號：K252643 · 2026-05-15

決定日期2026-05-15

產品代碼CAH

諮詢委員會AN

決定相當於

器材摘要

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.

常見問題

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?

FDA 510(k) 記錄將Teleflex Medical Sdn. Bhd. 列為申請人。這並不單獨確立設備製造商的身份。

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.

其他以 Teleflex Medical Sdn. Bhd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：CAH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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