FDA 510(k)

內科手術定位系統（IOPS®）

K 號：K243842 · 2025-03-06

決定日期2025-03-06

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®) 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 2025-03-06 under 510(k) number K243842. 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®)?

Intra-Operative Positioning System (IOPS®) is a medical device that received FDA 510(k) clearance on 2025-03-06. The listed applicant is Centerline Biomedical, Inc.. The 510(k) number is K243842.

When did Intra-Operative Positioning System (IOPS®) receive FDA 510(k) clearance?

Intra-Operative Positioning System (IOPS®) received FDA 510(k) clearance on 2025-03-06, under 510(k) number K243842.

Who is the listed applicant for Intra-Operative Positioning System (IOPS®)?

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®)?

The FDA product code for Intra-Operative Positioning System (IOPS®) is DQK.

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）K242133內科定位系統（IOPS®）（標記追蹤板）；內科定位系統（IOPS®）（導絲手柄）K241243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）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 Medical K262005Affera 整合地圖系統Medtronic, Inc.K253692AVVIGO™+ 多模態導引系統Boston Scientific K253576CorVista System® 內建 PCWP 附加功能Analytics For Life, Inc.K262006EnSite™ X EP 系統Abbott Medical K252978ScioCardio 心電圖分析平台Synergen Technology Labs, LLC

官方來源

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