FDA 510(k)

NC ROCKSTAR 非標準 PTCA 擴張球囊心导管

K 號：K222538 · 2022-12-21

申請人Sino Medical Sciences Technology, Inc.

決定日期2022-12-21

產品代碼LOX

諮詢委員會履歷

決定相當於

器材摘要

NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Sino Medical Sciences Technology, Inc.. It received FDA 510(k) clearance on 2022-12-21 under 510(k) number K222538. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter?

NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2022-12-21. The listed applicant is Sino Medical Sciences Technology, Inc.. The 510(k) number is K222538.

When did NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter receive FDA 510(k) clearance?

NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter received FDA 510(k) clearance on 2022-12-21, under 510(k) number K222538.

Who is the listed applicant for NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter?

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

What is the FDA product code for NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter?

The FDA product code for NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter is LOX.

其他以 Sino Medical Sciences Technology, 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。

K223022SC HONKYTONK PTCA 擴張球囊心导管

相關器械（代碼：LOX）

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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