FDA 510(k)

Zoom 6F 插入式心导管

K 號：K233975 · 2024-04-02

決定日期2024-04-02

產品代碼DQO

諮詢委員會履歷

決定相當於

器材摘要

Zoom 6F Insert Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Imperative Care, Inc.. It received FDA 510(k) clearance on 2024-04-02 under 510(k) number K233975. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Zoom 6F Insert Catheters?

Zoom 6F Insert Catheters is a medical device that received FDA 510(k) clearance on 2024-04-02. The listed applicant is Imperative Care, Inc.. The 510(k) number is K233975.

When did Zoom 6F Insert Catheters receive FDA 510(k) clearance?

Zoom 6F Insert Catheters received FDA 510(k) clearance on 2024-04-02, under 510(k) number K233975.

Who is the listed applicant for Zoom 6F Insert Catheters?

FDA 510(k) 記錄將 Imperative Care, 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 Zoom 6F Insert Catheters?

The FDA product code for Zoom 6F Insert Catheters is DQO.

其他以 Imperative Care, 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。

K261176Zoom 4S 管針 K252046Zoom 系統（Zoom 4S 穿刺針）K252057Symphony™ 靈栓切除系統及 Symphony™ 16F 82cm 靈栓切除系統 K244061X-Wire 導絲 K243047Zoom 7X 管子；Zoom 吸引管；Zoom POD 吸引管 K250775Symphony™ 靈栓切除系統；Symphony™ 16F 82cm 靈栓切除系統

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相關器械（代碼：DQO）

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。

K261455動脈壓力監測組/托盤Spectrum Vascular K252702生物優質肺動脈監測導管（TD2502NF、TD2502NGF、TD2502NDF、TD2502NCF、TD2502NCGF、TD2502NDGF、TD2502NDCF、TD2502NDCGF、TD2502NXCF、TD2502NDXF、TD2502NXCGF、TD2502NDXGF、TD2502NDXCF、TD2502NDXCGF、TD2502-110NF、TD2502-110NGF、TD2502-110NDF、TD2502-110NCF、TD2502-110NDGF、TD2502-110NDCF、TD2502-110NCGF、TD2502-110NDCGF、TD2502-110NXF、TD2502-110NXGF、TD2502-110NDXF、TD2502-110NXCF、TD2502-110NDXGF、TD2502-110NDXCF，TD2502-110NXCGF，TD2502-110NDXCGF，TD2602NF，TD2602N）Bioptimal International Pte. , Ltd.K254278動脈壓力監測組/托盤Spectrum Vascular K250751雙視窗導管Terumo Corporation K242966Gentuity® 高頻率OCT影像系統搭配Vis-Rx Prime® 微影像導管Gentuity, LLC K242420pNOVUS 21 微导管Phenox, Ltd.

官方來源

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