免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料,僅供一般參考,不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

M-CATH 微导管

K 號:K171176 · 2017-09-15

決定日期2017-09-15
產品代碼DQY
諮詢委員會履歷
決定相當於

器材摘要

M-CATH Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Acrostak (Schweiz) AG. It received FDA 510(k) clearance on 2017-09-15 under 510(k) number K171176. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the M-CATH Microcatheter?

M-CATH Microcatheter is a medical device that received FDA 510(k) clearance on 2017-09-15. The listed applicant is Acrostak (Schweiz) AG. The 510(k) number is K171176.

When did M-CATH Microcatheter receive FDA 510(k) clearance?

M-CATH Microcatheter received FDA 510(k) clearance on 2017-09-15, under 510(k) number K171176.

Who is the listed applicant for M-CATH Microcatheter?

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

What is the FDA product code for M-CATH Microcatheter?

The FDA product code for M-CATH Microcatheter is DQY.

相關臨床試驗

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。

相關器械(代碼:DQY)

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

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。

↑