FDA 510(k)

NES再處理視野PV .018數位內視鏡冠狀動脈內脈管（R-86700）

K 號：K250592 · 2025-05-12

決定日期2025-05-12

產品代碼OWQ

諮詢委員會履歷

決定相當於

器材摘要

NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) is the device name listed in this FDA 510(k) record. The listed applicant is Northeast Scientific, Inc.. It received FDA 510(k) clearance on 2025-05-12 under 510(k) number K250592. The device is classified under product code OWQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)?

NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) is a medical device that received FDA 510(k) clearance on 2025-05-12. The listed applicant is Northeast Scientific, Inc.. The 510(k) number is K250592.

When did NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) receive FDA 510(k) clearance?

NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) received FDA 510(k) clearance on 2025-05-12, under 510(k) number K250592.

Who is the listed applicant for NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)?

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

What is the FDA product code for NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)?

The FDA product code for NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) is OWQ.

其他以 Northeast Scientific, 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。

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相關器械（代碼：OWQ）

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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