FDA 510(k)

CVAC 吸引系統

K 號：K260965 · 2026-04-13

決定日期2026-04-13

產品代碼FED

諮詢委員會GU

決定相當於

器材摘要

CVAC Aspiration System is the device name listed in this FDA 510(k) record. The listed applicant is Calyxo, Inc.. It received FDA 510(k) clearance on 2026-04-13 under 510(k) number K260965. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CVAC Aspiration System?

CVAC Aspiration System is a medical device that received FDA 510(k) clearance on 2026-04-13. The listed applicant is Calyxo, Inc.. The 510(k) number is K260965.

When did CVAC Aspiration System receive FDA 510(k) clearance?

CVAC Aspiration System received FDA 510(k) clearance on 2026-04-13, under 510(k) number K260965.

Who is the listed applicant for CVAC Aspiration System?

FDA 510(k) 記錄將 Calyxo, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for CVAC Aspiration System?

The FDA product code for CVAC Aspiration System is FED.

其他以 Calyxo, 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：FED）

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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