FDA 510(k)

Z-6 心房中隔穿刺針

K 號：K211910 · 2021-07-19

決定日期2021-07-19

產品代碼DXF

諮詢委員會履歷

決定相當於

器材摘要

Z-6 Atrioseptostomy Catheter is the device name listed in this FDA 510(k) record. The listed applicant is NuMED, Inc.. It received FDA 510(k) clearance on 2021-07-19 under 510(k) number K211910. The device is classified under product code DXF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Z-6 Atrioseptostomy Catheter?

Z-6 Atrioseptostomy Catheter is a medical device that received FDA 510(k) clearance on 2021-07-19. The listed applicant is NuMED, Inc.. The 510(k) number is K211910.

When did Z-6 Atrioseptostomy Catheter receive FDA 510(k) clearance?

Z-6 Atrioseptostomy Catheter received FDA 510(k) clearance on 2021-07-19, under 510(k) number K211910.

Who is the listed applicant for Z-6 Atrioseptostomy Catheter?

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

What is the FDA product code for Z-6 Atrioseptostomy Catheter?

The FDA product code for Z-6 Atrioseptostomy Catheter is DXF.

其他以 NuMED, Inc. 為申請人之記錄

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相關器械（代碼：DXF）

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。

K261745雷電導管穿隔穿刺系統 (TPS)ElectroWire Medical K253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)Pressure Products Medical Device Manufacturing, LLC K260292HOTWIRE RF 線導管（901XXX）；HOTWIRE RF 線導管（902XXX）Atraverse Medical K252419HOTWIRE RF 線導管（901XXX）；HOTWIRE RF 線導管（902XXX）Atraverse Medical, Inc.K251007CrossWise RF 腺中隔進入系統（型號：CW-1085S、CW-1085A、CW-1012W、CW-1012C、CW-1085C、CW-1085V、CW-1013F）Circa Scientific, Inc.K243193Cross Wise™ 多功能RF轉接線Circa Scientific, Inc.

官方來源

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