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FDA 510(k)

13G InterV Kyphoplasty Catheter (Micro) 和 11G InterV Kyphoplasty Catheter (Mini-Flex)

K 號：K162453 · 2016-11-01

申請人Pan Medical , Ltd.
決定日期2016-11-01
產品代碼NDN
諮詢委員會或
決定相當於

器材摘要

13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) is the device name listed in this FDA 510(k) record. The listed applicant is Pan Medical , Ltd.. It received FDA 510(k) clearance on 2016-11-01 under 510(k) number K162453. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)?

13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) is a medical device that received FDA 510(k) clearance on 2016-11-01. The listed applicant is Pan Medical , Ltd.. The 510(k) number is K162453.

When did 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) receive FDA 510(k) clearance?

13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) received FDA 510(k) clearance on 2016-11-01, under 510(k) number K162453.

Who is the listed applicant for 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)?

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

What is the FDA product code for 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)?

The FDA product code for 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex) is NDN.

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。

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相關器械（代碼：NDN）

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。

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