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FDA 510(k)

安全九分 間隔導絲

K 號：K170671 · 2017-10-20

申請人Pressure Products Medical Device Manufacturing, LLC
決定日期2017-10-20
產品代碼DRC
諮詢委員會履歷
決定相當於

器材摘要

SafeSept Transseptal Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Pressure Products Medical Device Manufacturing, LLC. It received FDA 510(k) clearance on 2017-10-20 under 510(k) number K170671. The device is classified under product code DRC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SafeSept Transseptal Guidewire?

SafeSept Transseptal Guidewire is a medical device that received FDA 510(k) clearance on 2017-10-20. The listed applicant is Pressure Products Medical Device Manufacturing, LLC. The 510(k) number is K170671.

When did SafeSept Transseptal Guidewire receive FDA 510(k) clearance?

SafeSept Transseptal Guidewire received FDA 510(k) clearance on 2017-10-20, under 510(k) number K170671.

Who is the listed applicant for SafeSept Transseptal Guidewire?

The FDA 510(k) record lists Pressure Products Medical Device Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SafeSept Transseptal Guidewire?

The FDA product code for SafeSept Transseptal Guidewire is DRC.

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Pressure Products Medical Device Manufacturing, LLC 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。

K253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)K241042SafeSharp 門腔針 (CLICK071, CLICK171, CLICK098, CLICK198)K221707SafeSept® 間隔導絲（SS-140）K210328安全針刺器K181031TSI 腺中隔導入器K172950TSN 門腔針

查看所有 9 項裝置 →

相關器械（代碼：DRC）

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。

K240246Accusafe Transseptal Guidewire (GTR31180, GTR31230)Synaptic Medical CorporationK241042SafeSharp 門腔針 (CLICK071, CLICK171, CLICK098, CLICK198)Pressure Products Medical Device Manufacturing, LLCK221707SafeSept® 間隔導絲（SS-140）Pressure Products Medical Device Manufacturing, LLCK212625PathBuilder 門腔針Shanghai Microport EP Medtech Co., Ltd.K210328安全針刺器Pressure Products Medical Device Manufacturing, LLCK172950TSN 門腔針Pressure Products Medical Device Manufacturing, LLC

官方來源

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