FDA 510(k)

長鞘或LS，70公分，長鞘或LS，80公分，長鞘或LS，90公分

K 號：K152876 · 2016-01-08

決定日期2016-01-08

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM is the device name listed in this FDA 510(k) record. The listed applicant is Tni Manufacturing, Inc.. It received FDA 510(k) clearance on 2016-01-08 under 510(k) number K152876. 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 LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM?

LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM is a medical device that received FDA 510(k) clearance on 2016-01-08. The listed applicant is Tni Manufacturing, Inc.. The 510(k) number is K152876.

When did LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM receive FDA 510(k) clearance?

LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM received FDA 510(k) clearance on 2016-01-08, under 510(k) number K152876.

Who is the listed applicant for LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM?

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

What is the FDA product code for LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM?

The FDA product code for LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM is DQY.

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。

K262817CrossFAST整合式微导管先進輸送系統Vantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift 管針Alembic, LLC K262240SSPC NXT 輸送導管CenterPoint Systems, LLC K261766CPS 定位器 3D Plus 輸送导管CenterPoint Systems, LLC K261825Amplatzer TorqVue LP 運送系統; Amplatzer TorqVue LP 穿刺管Abbott

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。

器材摘要

常見問題

相關臨床試驗

相關器械（代碼：DQY）

官方來源