FDA 510(k)

虎眼CTO-Crossing 穿刺導管

K 號：K212468 · 2022-01-06

決定日期2022-01-06

產品代碼PDU

諮詢委員會履歷

決定相當於

器材摘要

Tigereye CTO-Crossing Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Avinger, Inc.. It received FDA 510(k) clearance on 2022-01-06 under 510(k) number K212468. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tigereye CTO-Crossing Catheter?

Tigereye CTO-Crossing Catheter is a medical device that received FDA 510(k) clearance on 2022-01-06. The listed applicant is Avinger, Inc.. The 510(k) number is K212468.

When did Tigereye CTO-Crossing Catheter receive FDA 510(k) clearance?

Tigereye CTO-Crossing Catheter received FDA 510(k) clearance on 2022-01-06, under 510(k) number K212468.

Who is the listed applicant for Tigereye CTO-Crossing Catheter?

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

What is the FDA product code for Tigereye CTO-Crossing Catheter?

The FDA product code for Tigereye CTO-Crossing Catheter is PDU.

其他以 Avinger, Inc. 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。

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相關器械（代碼：PDU）

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

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