FDA 510(k)

NuCath 鋸齒壓力心臟导管

K 號：K213666 · 2022-10-06

決定日期2022-10-06

產品代碼DQO

諮詢委員會履歷

決定相當於

器材摘要

NuCath Wedge Pressure Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Pfm Medical, Inc.. It received FDA 510(k) clearance on 2022-10-06 under 510(k) number K213666. 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 NuCath Wedge Pressure Catheter?

NuCath Wedge Pressure Catheter is a medical device that received FDA 510(k) clearance on 2022-10-06. The listed applicant is Pfm Medical, Inc.. The 510(k) number is K213666.

When did NuCath Wedge Pressure Catheter receive FDA 510(k) clearance?

NuCath Wedge Pressure Catheter received FDA 510(k) clearance on 2022-10-06, under 510(k) number K213666.

Who is the listed applicant for NuCath Wedge Pressure Catheter?

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

What is the FDA product code for NuCath Wedge Pressure Catheter?

The FDA product code for NuCath Wedge Pressure Catheter is DQO.

其他以 Pfm Medical, Inc. 為申請人之記錄

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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.

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