飛彈導引護套
K 號：K240957 · 2024-08-14
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器材摘要
Catapult Guide Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Contract Medical International, GmbH. It received FDA 510(k) clearance on 2024-08-14 under 510(k) number K240957. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Catapult Guide Sheath?
Catapult Guide Sheath is a medical device that received FDA 510(k) clearance on 2024-08-14. The listed applicant is Contract Medical International, GmbH. The 510(k) number is K240957.
When did Catapult Guide Sheath receive FDA 510(k) clearance?
Catapult Guide Sheath received FDA 510(k) clearance on 2024-08-14, under 510(k) number K240957.
Who is the listed applicant for Catapult Guide Sheath?
The FDA 510(k) record lists Contract Medical International, GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Catapult Guide Sheath?
The FDA product code for Catapult Guide Sheath is DYB.
相關臨床試驗
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其他以 Contract Medical International, GmbH 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。
K250439Catapult 引導鞘；4F；15cm（US-34015-F-ST-H）；Catapult 引導鞘；4F；45cm（US-34045-F-ST-H）；Catapult 引導鞘；4F；60cm（US-34060-F-ST-H）；Catapult 引導鞘；4F；90cm（US-34090-F-ST-H）；Catapult 引導鞘；4F；130cm（US-34130-F-ST-H）；Catapult 引導鞘；5F；15cm（US-35015-F-ST-H）；Catapult 引導鞘；5F；45cm（US-35045-F-ST-H）；Catapult 引導鞘；5F；45cm；曲棍球棒型（US-35045-F-HS-H）；Catapult 引導鞘；5F；45cm；多用途（US-35045-F-MP-H）；CaK221914飛彈導引護套K203179堡壘導入鞘系統K181463DuraSheath 引導鞘系統K153197堡壘導入鞘系統
相關器械（代碼：DYB）
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。
K253526NAMIC 扩張器及套管Medline Industries, LPK261529微穿刺套件 / 微穿刺接入套件 / 微穿刺導入器組 / 微導入器套件 / 微導入器套件（SIS05C）；微穿刺套件 / 微穿刺接入套件 / 微穿刺導入器組 / 微導入器套件 / 微導入器套件（IS01）；導入器套件 / 微導入器套件 / 導入器組 / 微導入器組 / 微導入器鞘組 / 導入器鞘組（NIS04）Hartman Medical Group, LLCK261242簡易導引PendracareK261950健康線拆離導入器Health Line International CorporationK261492FieldFlex 經導鞘CenterPoint Systems, LLCK260606回聲大內徑導入鞘Echo Medical, LLC
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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