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FDA 510(k)

HAART 200 鳶尾環成形術設備 19mm，HAART 200 鳶尾環成形術設備 21mm，HAART 200 鳶尾環成形術設備 23mm，HAART 200 鳶尾環成形術設備 25mm

K 號：K171431 · 2017-08-10

申請人Biostable Science & Engineering, Inc.
決定日期2017-08-10
產品代碼PST
諮詢委員會履歷
決定相當於

器材摘要

HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm is the device name listed in this FDA 510(k) record. The listed applicant is Biostable Science & Engineering, Inc.. It received FDA 510(k) clearance on 2017-08-10 under 510(k) number K171431. The device is classified under product code PST. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm?

HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm is a medical device that received FDA 510(k) clearance on 2017-08-10. The listed applicant is Biostable Science & Engineering, Inc.. The 510(k) number is K171431.

When did HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm receive FDA 510(k) clearance?

HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm received FDA 510(k) clearance on 2017-08-10, under 510(k) number K171431.

Who is the listed applicant for HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm?

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

What is the FDA product code for HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm?

The FDA product code for HAART 200 Aortic Annuloplasty Device 19mm, HAART 200 Aortic Annuloplasty Device 21mm, HAART 200 Aortic Annuloplasty Device 23mm, HAART 200 Aortic Annuloplasty Device 25mm is PST.

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 Biostable Science & Engineering, Inc. 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。

K163608HAART 300 鳶尾環成形術設備 19mm，HAART 300 鳶尾環成形術設備 21mm，HAART 300 鳶尾環成形術設備 23mm，HAART 300 鳶尾環成形術設備 25mm

相關器械（代碼：PST）

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。

K163608HAART 300 鳶尾環成形術設備 19mm，HAART 300 鳶尾環成形術設備 21mm，HAART 300 鳶尾環成形術設備 23mm，HAART 300 鳶尾環成形術設備 25mmBiostable Science & Engineering, Inc.

官方來源

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