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FDA 510(k)

Agile Devices Angler Steerable, Deflectable Microcatheter

K 號:K211110 · 2022-01-07

決定日期2022-01-07
產品代碼KRA
諮詢委員會履歷
決定相當於

器材摘要

Agile Devices Angler Steerable, Deflectable Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Agile Devices, Inc.. It received FDA 510(k) clearance on 2022-01-07 under 510(k) number K211110. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Agile Devices Angler Steerable, Deflectable Microcatheter?

Agile Devices Angler Steerable, Deflectable Microcatheter is a medical device that received FDA 510(k) clearance on 2022-01-07. The listed applicant is Agile Devices, Inc.. The 510(k) number is K211110.

When did Agile Devices Angler Steerable, Deflectable Microcatheter receive FDA 510(k) clearance?

Agile Devices Angler Steerable, Deflectable Microcatheter received FDA 510(k) clearance on 2022-01-07, under 510(k) number K211110.

Who is the listed applicant for Agile Devices Angler Steerable, Deflectable Microcatheter?

The FDA 510(k) record lists Agile Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Agile Devices Angler Steerable, Deflectable Microcatheter?

The FDA product code for Agile Devices Angler Steerable, Deflectable Microcatheter is KRA.

相關臨床試驗

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相關器械(代碼:KRA)

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。

官方來源

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