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FDA 510(k)

視覺空氣強化型支架

K 號:K261541 · 2026-06-01

決定日期2026-06-01
產品代碼NWA
諮詢委員會SU 請提供完整的描述文本,以便我進行翻譯。
決定相當於

器材摘要

VisionAir Enhanced Stock Stent is the device name listed in this FDA 510(k) record. The listed applicant is VisionAir Solutions. It received FDA 510(k) clearance on 2026-06-01 under 510(k) number K261541. The device is classified under product code NWA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VisionAir Enhanced Stock Stent?

VisionAir Enhanced Stock Stent is a medical device that received FDA 510(k) clearance on 2026-06-01. The listed applicant is VisionAir Solutions. The 510(k) number is K261541.

When did VisionAir Enhanced Stock Stent receive FDA 510(k) clearance?

VisionAir Enhanced Stock Stent received FDA 510(k) clearance on 2026-06-01, under 510(k) number K261541.

Who is the listed applicant for VisionAir Enhanced Stock Stent?

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

What is the FDA product code for VisionAir Enhanced Stock Stent?

The FDA product code for VisionAir Enhanced Stock Stent is NWA.

相關臨床試驗

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相關器械(代碼:NWA)

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。

官方來源

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