FDA 510(k)

生物設計橫隔膜裂移植片

K 號：K171817 · 2018-03-13

決定日期2018-03-13

產品代碼FTM

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Biodesign Diaphragmatic Hernia Graft is the device name listed in this FDA 510(k) record. The listed applicant is Cook Biotech Incorporated. It received FDA 510(k) clearance on 2018-03-13 under 510(k) number K171817. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Biodesign Diaphragmatic Hernia Graft?

Biodesign Diaphragmatic Hernia Graft is a medical device that received FDA 510(k) clearance on 2018-03-13. The listed applicant is Cook Biotech Incorporated. The 510(k) number is K171817.

When did Biodesign Diaphragmatic Hernia Graft receive FDA 510(k) clearance?

Biodesign Diaphragmatic Hernia Graft received FDA 510(k) clearance on 2018-03-13, under 510(k) number K171817.

Who is the listed applicant for Biodesign Diaphragmatic Hernia Graft?

The FDA 510(k) record lists Cook Biotech Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Biodesign Diaphragmatic Hernia Graft?

The FDA product code for Biodesign Diaphragmatic Hernia Graft is FTM.

其他以 Cook Biotech Incorporated 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。

K232646生物設計耳科蝴蝶移植片（ENT-OTO-BFLY-0.4-0.6）；生物設計耳科蝴蝶移植片（ENT-OTO-BFLY-0.6-0.9）K201000生物設計釘線加固設備 K191696生物設計肛門瘍塞，生物設計瘍塞，生物設計整形外科網格，生物設計組織移植 K162934生物設計旁肛門裂孔修復移植物 K170016生物設計造口塞 K170945生物設計釘線加固設備

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相關器械（代碼：FTM）

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。

K262406EluPro 抗生素釋放生物包膜Boston Scientific K250598Endoform 重構模板 - PLGAAroa Biosurgery , Ltd.K243595OviTex PRS（長期可吸收）TELA Bio, Inc.K233991CanGaroo RM 抗菌信封Elutia, Inc.K241126OviTex PRSTELA Bio, Inc.K223052Peri-Guard 及Supple Peri-GuardSynovis Life Technologies, Inc.

官方來源

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