催化
K 號：K253204 · 2026-06-05
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器材摘要
Catalyze is the device name listed in this FDA 510(k) record. The listed applicant is BioTissue Holdings, Inc.. It received FDA 510(k) clearance on 2026-06-05 under 510(k) number K253204. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.
常見問題
What is the Catalyze?
Catalyze is a medical device that received FDA 510(k) clearance on 2026-06-05. The listed applicant is BioTissue Holdings, Inc.. The 510(k) number is K253204.
When did Catalyze receive FDA 510(k) clearance?
Catalyze received FDA 510(k) clearance on 2026-06-05, under 510(k) number K253204.
Who is the listed applicant for Catalyze?
The FDA 510(k) record lists BioTissue Holdings, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Catalyze?
The FDA product code for Catalyze is KGN.
相關臨床試驗
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。
相關器械（代碼：KGN）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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