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FDA 510(k)

內科定位系統（IOPS®）（標記追蹤板）；內科定位系統（IOPS®）（導絲手柄）

K 號：K242133 · 2024-10-11

申請人Centerline Biomedical, Inc.
決定日期2024-10-11
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®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) 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 2024-10-11 under 510(k) number K242133. 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®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle)?

Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) is a medical device that received FDA 510(k) clearance on 2024-10-11. The listed applicant is Centerline Biomedical, Inc.. The 510(k) number is K242133.

When did Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) receive FDA 510(k) clearance?

Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) received FDA 510(k) clearance on 2024-10-11, under 510(k) number K242133.

Who is the listed applicant for Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle)?

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®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle)?

The FDA product code for Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle) 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。

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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®）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。

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官方來源

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