FDA 510(k)

XableCath 穿刺導管

K 號：K183357 · 2019-01-21

決定日期2019-01-21

產品代碼PDU

諮詢委員會履歷

決定相當於

器材摘要

XableCath Crossing Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Xablecath, Inc.. It received FDA 510(k) clearance on 2019-01-21 under 510(k) number K183357. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the XableCath Crossing Catheter?

XableCath Crossing Catheter is a medical device that received FDA 510(k) clearance on 2019-01-21. The listed applicant is Xablecath, Inc.. The 510(k) number is K183357.

When did XableCath Crossing Catheter receive FDA 510(k) clearance?

XableCath Crossing Catheter received FDA 510(k) clearance on 2019-01-21, under 510(k) number K183357.

Who is the listed applicant for XableCath Crossing Catheter?

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

What is the FDA product code for XableCath Crossing Catheter?

The FDA product code for XableCath Crossing Catheter is PDU.

其他以 Xablecath, Inc. 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。

K180986XableCath 支援導管產品系列 K170041XableCath 支援導管

相關器械（代碼：PDU）

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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