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FDA 510(k)

BosCATH 支援導管

K 號：K254046 · 2026-04-21

申請人Sonorous NV, Inc.
決定日期2026-04-21
產品代碼QJP
諮詢委員會履歷
決定相當於

器材摘要

BosCATH Support Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Sonorous NV, Inc.. It received FDA 510(k) clearance on 2026-04-21 under 510(k) number K254046. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BosCATH Support Catheter?

BosCATH Support Catheter is a medical device that received FDA 510(k) clearance on 2026-04-21. The listed applicant is Sonorous NV, Inc.. The 510(k) number is K254046.

When did BosCATH Support Catheter receive FDA 510(k) clearance?

BosCATH Support Catheter received FDA 510(k) clearance on 2026-04-21, under 510(k) number K254046.

Who is the listed applicant for BosCATH Support Catheter?

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

What is the FDA product code for BosCATH Support Catheter?

The FDA product code for BosCATH Support Catheter is QJP.

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相關器械（代碼：QJP）

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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