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FDA 510(k)

純淨血液透析針管

K 號：K182443 · 2019-05-31

申請人Pristine Access Technologies , Ltd.
決定日期2019-05-31
產品代碼MSD
諮詢委員會GU
決定相當於

器材摘要

Pristine Hemodialysis Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Pristine Access Technologies , Ltd.. It received FDA 510(k) clearance on 2019-05-31 under 510(k) number K182443. The device is classified under product code MSD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pristine Hemodialysis Catheter?

Pristine Hemodialysis Catheter is a medical device that received FDA 510(k) clearance on 2019-05-31. The listed applicant is Pristine Access Technologies , Ltd.. The 510(k) number is K182443.

When did Pristine Hemodialysis Catheter receive FDA 510(k) clearance?

Pristine Hemodialysis Catheter received FDA 510(k) clearance on 2019-05-31, under 510(k) number K182443.

Who is the listed applicant for Pristine Hemodialysis Catheter?

The FDA 510(k) record lists Pristine Access Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pristine Hemodialysis Catheter?

The FDA product code for Pristine Hemodialysis Catheter is MSD.

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

相關器械（代碼：MSD）

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。

K241581血液透析針管Haolang Medical USA CorporationK210461終端蓋Medical Components Inc (Medcomp)K203575GlidePath 長期血液透析導管C.R. Bard, Inc.K211410GlidePath 13F 長期血液透析針管Bard Peripheral Vascular, Inc.K203767純淨長期血液透析針管C B Bard, Inc.K202150GlidePath 7.5F 長期透析針管C.R. Bard, Inc.

官方來源

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