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FDA PMA

導管,經皮(瓣膜成形術)

PMA 核准號:P910054 · 2024-07-01

決定日期2024-07-01
PMA 編號P910054
產品代碼MAD
器械分類3 類
醫療專科U
諮詢委員會履歷

器材摘要

CATHETER, PERCUTANEOUS (VALVULOPLASTY) is the device name listed in this FDA 510(k) record. The listed applicant is Toray Industries (America), Inc.. It received FDA 510(k) clearance on 2024-07-01. The device is classified under product code MAD. It was reviewed by the CV advisory panel.

常見問題

What is the CATHETER, PERCUTANEOUS (VALVULOPLASTY)?

CATHETER, PERCUTANEOUS (VALVULOPLASTY) is a medical device that received FDA 510(k) clearance on 2024-07-01. The listed applicant is Toray Industries (America), Inc..

When did CATHETER, PERCUTANEOUS (VALVULOPLASTY) receive FDA 510(k) clearance?

The clearance date for CATHETER, PERCUTANEOUS (VALVULOPLASTY) can be found in the official FDA records.

Who is the listed applicant for CATHETER, PERCUTANEOUS (VALVULOPLASTY)?

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

What is the FDA product code for CATHETER, PERCUTANEOUS (VALVULOPLASTY)?

The FDA product code for CATHETER, PERCUTANEOUS (VALVULOPLASTY) is MAD.

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