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FDA PMA

設備,血管成形術,雷射,冠狀

PMA 核准號:P910001 · 2026-08-21

決定日期2026-08-21
PMA 編號P910001
產品代碼LPC
器械分類3 類
醫療專科U
諮詢委員會履歷

器材摘要

DEVICE, ANGIOPLASTY, LASER, CORONARY is the device name listed in this FDA 510(k) record. The listed applicant is Spectranetics Corp.. It received FDA 510(k) clearance on 2026-08-21. The device is classified under product code LPC. It was reviewed by the CV advisory panel.

常見問題

What is the DEVICE, ANGIOPLASTY, LASER, CORONARY?

DEVICE, ANGIOPLASTY, LASER, CORONARY is a medical device that received FDA 510(k) clearance on 2026-08-21. The listed applicant is Spectranetics Corp..

When did DEVICE, ANGIOPLASTY, LASER, CORONARY receive FDA 510(k) clearance?

The clearance date for DEVICE, ANGIOPLASTY, LASER, CORONARY can be found in the official FDA records.

Who is the listed applicant for DEVICE, ANGIOPLASTY, LASER, CORONARY?

The FDA 510(k) record lists Spectranetics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEVICE, ANGIOPLASTY, LASER, CORONARY?

The FDA product code for DEVICE, ANGIOPLASTY, LASER, CORONARY is LPC.

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官方來源

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