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FDA 510(k)

內科定位系統（IOPS®）視角（簡易曲管心导管）；內科定位系統（IOPS®）視角（雙曲管心导管）

K 號：K241243 · 2024-07-24

申請人Centerline Biomedical, Inc.
決定日期2024-07-24
產品代碼DQK
諮詢委員會履歷
決定相當於

器材摘要

Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) is the device name listed in this FDA 510(k) record. The listed applicant is Centerline Biomedical, Inc.. It received FDA 510(k) clearance on 2024-07-24 under 510(k) number K241243. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters)?

Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) is a medical device that received FDA 510(k) clearance on 2024-07-24. The listed applicant is Centerline Biomedical, Inc.. The 510(k) number is K241243.

When did Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) receive FDA 510(k) clearance?

Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) received FDA 510(k) clearance on 2024-07-24, under 510(k) number K241243.

Who is the listed applicant for Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters)?

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

What is the FDA product code for Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters)?

The FDA product code for Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters) is DQK.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Centerline Biomedical, 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。

K254089IOPS 領先系統 (MC-3)；IOPS 觀點簡曲導管，75cm（C00751）；IOPS 觀點簡曲導管，125cm（C01251）；IOPS 觀點雙曲導管，75cm（C00752）；IOPS 觀點雙曲導管，125cm（C02152）；IOPS 導絲 2（ATW-2）；IOPS 專用跟蹤墊（T02111）；IOPS 導絲手柄（H01035）K243842內科手術定位系統（IOPS®）K242133內科定位系統（IOPS®）（標記追蹤板）；內科定位系統（IOPS®）（導絲手柄）K230309內科定位系統（IOPS®）(MC-1)；IOPS 簡曲導管（SCC-1）及 IOPS 反曲導管（RCC-1）；IOPS 導絲（ATW-2）；IOPS 追蹤板（TP-1）；IOPS 導絲手柄（SSH-1）K190106內科定位系統；簡易曲度心导管，逆向曲度心导管；斜尖導絲；跟蹤板；導絲手柄

相關器械（代碼：DQK）

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。

K261729EnSite™ X EP 系統Abbott MedicalK262005Affera 整合地圖系統Medtronic, Inc.K253692AVVIGO™+ 多模態導引系統Boston ScientificK253576CorVista System® 內建 PCWP 附加功能Analytics For Life, Inc.K262006EnSite™ X EP 系統Abbott MedicalK252978ScioCardio 心電圖分析平台Synergen Technology Labs, LLC

官方來源

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