FDA 510(k)

Makoto 開放性動脈內影像系統，雙功能 IVUS + NIRS 設備導管

K 號：K183599 · 2019-04-12

決定日期2019-04-12

產品代碼OGZ

諮詢委員會履歷

決定相當於

器材摘要

Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Infraredx, Inc.. It received FDA 510(k) clearance on 2019-04-12 under 510(k) number K183599. The device is classified under product code OGZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter?

Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter is a medical device that received FDA 510(k) clearance on 2019-04-12. The listed applicant is Infraredx, Inc.. The 510(k) number is K183599.

When did Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter receive FDA 510(k) clearance?

Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter received FDA 510(k) clearance on 2019-04-12, under 510(k) number K183599.

Who is the listed applicant for Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter?

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

What is the FDA product code for Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter?

The FDA product code for Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter is OGZ.

其他以 Infraredx, 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。

K241576Makoto 開放性動脈內影像系統™ (VC-MC10 / TVC-MC10i)；雙功能™ IVUS+NIRS 許可性導管 (TVC-C195-42)；周邊 014 許可性導管 (TVC-E195-42)K213303Makoto 開放性動脈內影像系統，TVC-MC10/TVC-MC10i，雙功能 IVUS + NIRS 許配器，TVC-C195-42，周邊 014 許配器，TVC-E195-42 K163345TVC影像系統，TVC心导管

相關器械（代碼：OGZ）

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。

K241576Makoto 開放性動脈內影像系統™ (VC-MC10 / TVC-MC10i)；雙功能™ IVUS+NIRS 許可性導管 (TVC-C195-42)；周邊 014 許可性導管 (TVC-E195-42)Infraredx, Inc.K163345TVC影像系統，TVC心导管Infraredx, Inc.

官方來源

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