FDA 510(k)

SafeSharp 門腔針 (CLICK071, CLICK171, CLICK098, CLICK198)

K 號：K241042 · 2024-05-17

申請人Pressure Products Medical Device Manufacturing, LLC

決定日期2024-05-17

產品代碼DRC

諮詢委員會履歷

決定相當於

器材摘要

SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) 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 2024-05-17 under 510(k) number K241042. 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 SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)?

SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) is a medical device that received FDA 510(k) clearance on 2024-05-17. The listed applicant is Pressure Products Medical Device Manufacturing, LLC. The 510(k) number is K241042.

When did SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) receive FDA 510(k) clearance?

SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) received FDA 510(k) clearance on 2024-05-17, under 510(k) number K241042.

Who is the listed applicant for SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)?

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 SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)?

The FDA product code for SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) is DRC.

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)K221707SafeSept® 間隔導絲（SS-140）K210328安全針刺器 K181031TSI 腺中隔導入器 K172950TSN 門腔針 K172934針無法穿隔心腔針管

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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 Corporation K221707SafeSept® 間隔導絲（SS-140）Pressure Products Medical Device Manufacturing, LLC K212625PathBuilder 門腔針Shanghai Microport EP Medtech Co., Ltd.K210328安全針刺器Pressure Products Medical Device Manufacturing, LLC K172950TSN 門腔針Pressure Products Medical Device Manufacturing, LLC K172934針無法穿隔心腔針管Pressure Products Medical Device Manufacturing, LLC

官方來源

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