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FDA PMA

導管,冠狀動脈,動脈內脫落術

PMA 核准號:P130005 · 2026-03-10

決定日期2026-03-10
PMA 編號P130005
產品代碼MCX
器械分類3 類
醫療專科U
諮詢委員會履歷

器材摘要

CATHETER, CORONARY, ATHERECTOMY is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Systems, Inc.. It received FDA 510(k) clearance on 2026-03-10. The device is classified under product code MCX. It was reviewed by the CV advisory panel.

常見問題

What is the CATHETER, CORONARY, ATHERECTOMY?

CATHETER, CORONARY, ATHERECTOMY is a medical device that received FDA 510(k) clearance on 2026-03-10. The listed applicant is Cardiovascular Systems, Inc..

When did CATHETER, CORONARY, ATHERECTOMY receive FDA 510(k) clearance?

The clearance date for CATHETER, CORONARY, ATHERECTOMY can be found in the official FDA records.

Who is the listed applicant for CATHETER, CORONARY, ATHERECTOMY?

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

What is the FDA product code for CATHETER, CORONARY, ATHERECTOMY?

The FDA product code for CATHETER, CORONARY, ATHERECTOMY is MCX.

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官方來源

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