FDA 510(k)

XO 分數經皮腔內血管成形術評分導管

K 號：K193495 · 2020-05-29

決定日期2020-05-29

產品代碼PNO

諮詢委員會履歷

決定相當於

器材摘要

XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Transit Scientific. It received FDA 510(k) clearance on 2020-05-29 under 510(k) number K193495. The device is classified under product code PNO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the XO Score Percutaneous Transluminal Angioplasty Scoring Catheter?

XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is a medical device that received FDA 510(k) clearance on 2020-05-29. The listed applicant is Transit Scientific. The 510(k) number is K193495.

When did XO Score Percutaneous Transluminal Angioplasty Scoring Catheter receive FDA 510(k) clearance?

XO Score Percutaneous Transluminal Angioplasty Scoring Catheter received FDA 510(k) clearance on 2020-05-29, under 510(k) number K193495.

Who is the listed applicant for XO Score Percutaneous Transluminal Angioplasty Scoring Catheter?

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

What is the FDA product code for XO Score Percutaneous Transluminal Angioplasty Scoring Catheter?

The FDA product code for XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is PNO.

其他以 Transit Scientific 為申請人之記錄

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。

K193420XO橫向支撐導管

相關器械（代碼：PNO）

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。

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官方來源

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