FDA 510(k)

核心M2血管系統

K 號：K170385 · 2017-04-06

決定日期2017-04-06

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

CORE M2 Vascular System is the device name listed in this FDA 510(k) record. The listed applicant is Volcano Corporation. It received FDA 510(k) clearance on 2017-04-06 under 510(k) number K170385. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CORE M2 Vascular System?

CORE M2 Vascular System is a medical device that received FDA 510(k) clearance on 2017-04-06. The listed applicant is Volcano Corporation. The 510(k) number is K170385.

When did CORE M2 Vascular System receive FDA 510(k) clearance?

CORE M2 Vascular System received FDA 510(k) clearance on 2017-04-06, under 510(k) number K170385.

Who is the listed applicant for CORE M2 Vascular System?

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

What is the FDA product code for CORE M2 Vascular System?

The FDA product code for CORE M2 Vascular System is IYO.

其他以 Volcano Corporation 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。

K210235Verrata PLUS 压力導引針 K203719內視眼手機 K202543OmniWire 壓力導引針，185 cm 直尖，OmniWire 壓力導引針，185 cm J尖 K192886OmniWire 壓力導引針，185 cm 直尖，OmniWire 壓力導引針，185 cm J尖 K190626同步視覺系統 K190078內視眼

查看所有 13 項裝置 →

相關器械（代碼：IYO）

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。

K260313MD-6000S 膀胱掃描儀MEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApS K252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT 扫描儀 2000 型號 AQT Imaging Holdings, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。