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FDA 510(k)

AMPLATZER TorqVue 45x45 運送鞘

K 號：K163000 · 2016-12-23

申請人Aga Medical COrporation (Wholly Owned by St. Jude Medical CO
決定日期2016-12-23
產品代碼DQY
諮詢委員會履歷
決定相當於

器材摘要

AMPLATZER TorqVue 45x45 Delivery Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Aga Medical COrporation (Wholly Owned by St. Jude Medical CO. It received FDA 510(k) clearance on 2016-12-23 under 510(k) number K163000. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AMPLATZER TorqVue 45x45 Delivery Sheath?

AMPLATZER TorqVue 45x45 Delivery Sheath is a medical device that received FDA 510(k) clearance on 2016-12-23. The listed applicant is Aga Medical COrporation (Wholly Owned by St. Jude Medical CO. The 510(k) number is K163000.

When did AMPLATZER TorqVue 45x45 Delivery Sheath receive FDA 510(k) clearance?

AMPLATZER TorqVue 45x45 Delivery Sheath received FDA 510(k) clearance on 2016-12-23, under 510(k) number K163000.

Who is the listed applicant for AMPLATZER TorqVue 45x45 Delivery Sheath?

The FDA 510(k) record lists Aga Medical COrporation (Wholly Owned by St. Jude Medical CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMPLATZER TorqVue 45x45 Delivery Sheath?

The FDA product code for AMPLATZER TorqVue 45x45 Delivery Sheath is DQY.

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。

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相關器械（代碼：DQY）

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。

K262817CrossFAST整合式微导管先進輸送系統Vantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift 管針Alembic, LLCK262240SSPC NXT 輸送導管CenterPoint Systems, LLCK261766CPS 定位器 3D Plus 輸送导管CenterPoint Systems, LLCK261825Amplatzer TorqVue LP 運送系統; Amplatzer TorqVue LP 穿刺管Abbott

官方來源

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