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FDA 510(k)

IOPS 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）

K 號：K254089 · 2026-02-17

申請人Centerline Biomedical, Inc.
決定日期2026-02-17
產品代碼DQK
諮詢委員會履歷
決定相當於

器材摘要

IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) 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 2026-02-17 under 510(k) number K254089. 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 IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035)?

IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) is a medical device that received FDA 510(k) clearance on 2026-02-17. The listed applicant is Centerline Biomedical, Inc.. The 510(k) number is K254089.

When did IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) receive FDA 510(k) clearance?

IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) received FDA 510(k) clearance on 2026-02-17, under 510(k) number K254089.

Who is the listed applicant for IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035)?

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 IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035)?

The FDA product code for IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) 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。

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）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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