FDA 510(k)

INFINITI™ 雙向顯影導管

K 號：K232573 · 2023-11-21

決定日期2023-11-21

產品代碼DQO

諮詢委員會履歷

決定相當於

器材摘要

INFINITI™ Ambi Angiographic Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cordis US Corp. It received FDA 510(k) clearance on 2023-11-21 under 510(k) number K232573. 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 INFINITI™ Ambi Angiographic Catheter?

INFINITI™ Ambi Angiographic Catheter is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Cordis US Corp. The 510(k) number is K232573.

When did INFINITI™ Ambi Angiographic Catheter receive FDA 510(k) clearance?

INFINITI™ Ambi Angiographic Catheter received FDA 510(k) clearance on 2023-11-21, under 510(k) number K232573.

Who is the listed applicant for INFINITI™ Ambi Angiographic Catheter?

The FDA 510(k) record lists Cordis US Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFINITI™ Ambi Angiographic Catheter?

The FDA product code for INFINITI™ Ambi Angiographic Catheter is DQO.

其他以 Cordis US Corp 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。

K233637Cordis BRITECROSS 支援導管 K230704RAIN Sheath™ 靈骨腳導入器 K221832SABER .014 PTA 膨脹導管；SABERX .014 PTA 膨脹導管

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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