FDA 510(k)

Provisio™ SLT IVUS™ 系統

K 號：K233948 · 2024-04-23

決定日期2024-04-23

產品代碼OBJ

諮詢委員會履歷

決定相當於

器材摘要

Provisio™ SLT IVUS™ System is the device name listed in this FDA 510(k) record. The listed applicant is Provisio Medical, Inc.. It received FDA 510(k) clearance on 2024-04-23 under 510(k) number K233948. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Provisio™ SLT IVUS™ System?

Provisio™ SLT IVUS™ System is a medical device that received FDA 510(k) clearance on 2024-04-23. The listed applicant is Provisio Medical, Inc.. The 510(k) number is K233948.

When did Provisio™ SLT IVUS™ System receive FDA 510(k) clearance?

Provisio™ SLT IVUS™ System received FDA 510(k) clearance on 2024-04-23, under 510(k) number K233948.

Who is the listed applicant for Provisio™ SLT IVUS™ System?

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

What is the FDA product code for Provisio™ SLT IVUS™ System?

The FDA product code for Provisio™ SLT IVUS™ System is OBJ.

相關器械（代碼：OBJ）

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：OBJ）

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