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FDA 510(k)

Prestige 環繞系統

K 號：K220699 · 2022-04-08

申請人Bait USA, LLC
決定日期2022-04-08
產品代碼KRD
諮詢委員會履歷
決定相當於

器材摘要

Prestige Coil System is the device name listed in this FDA 510(k) record. The listed applicant is Bait USA, LLC. It received FDA 510(k) clearance on 2022-04-08 under 510(k) number K220699. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Prestige Coil System?

Prestige Coil System is a medical device that received FDA 510(k) clearance on 2022-04-08. The listed applicant is Bait USA, LLC. The 510(k) number is K220699.

When did Prestige Coil System receive FDA 510(k) clearance?

Prestige Coil System received FDA 510(k) clearance on 2022-04-08, under 510(k) number K220699.

Who is the listed applicant for Prestige Coil System?

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

What is the FDA product code for Prestige Coil System?

The FDA product code for Prestige Coil System is KRD.

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：KRD）

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。

K252812UniPearls® 遮斷微膠球Suzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO 可調適性栓塊Boston Scientific CorporationK261866Concerto Versa™ 可拆式線圈Medtronic, Inc.K260635HARBOR 閉塞設備Nuvascular, Inc.K260508LOBO血管栓塞系統Okami Medical, Inc.K253511Concerto Versa™ 可拆式線圈Medtronic, Inc.

官方來源

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