FDA 510(k)

TVC影像系統，TVC心导管

K 號：K163345 · 2017-06-21

決定日期2017-06-21

產品代碼OGZ

諮詢委員會履歷

決定相當於

器材摘要

TVC Imaging System, TVC 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 2017-06-21 under 510(k) number K163345. 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 TVC Imaging System, TVC Catheter?

TVC Imaging System, TVC Catheter is a medical device that received FDA 510(k) clearance on 2017-06-21. The listed applicant is Infraredx, Inc.. The 510(k) number is K163345.

When did TVC Imaging System, TVC Catheter receive FDA 510(k) clearance?

TVC Imaging System, TVC Catheter received FDA 510(k) clearance on 2017-06-21, under 510(k) number K163345.

Who is the listed applicant for TVC Imaging System, TVC 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 TVC Imaging System, TVC Catheter?

The FDA product code for TVC Imaging System, TVC 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 K183599Makoto 開放性動脈內影像系統，雙功能 IVUS + NIRS 設備導管

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.K183599Makoto 開放性動脈內影像系統，雙功能 IVUS + NIRS 設備導管Infraredx, Inc.

官方來源

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