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FDA 510(k)

改良型Kyphoplasty用懸吊器（15及20毫米）11釐米氣球導管

K 號：K172214 · 2017-08-23

申請人G-21 S.R.L.
決定日期2017-08-23
產品代碼NDN
諮詢委員會或
決定相當於

器材摘要

Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters is the device name listed in this FDA 510(k) record. The listed applicant is G-21 S.R.L.. It received FDA 510(k) clearance on 2017-08-23 under 510(k) number K172214. 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 Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters?

Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters is a medical device that received FDA 510(k) clearance on 2017-08-23. The listed applicant is G-21 S.R.L.. The 510(k) number is K172214.

When did Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters receive FDA 510(k) clearance?

Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters received FDA 510(k) clearance on 2017-08-23, under 510(k) number K172214.

Who is the listed applicant for Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters?

The FDA 510(k) record lists G-21 S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters?

The FDA product code for Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters is NDN.

相關臨床試驗

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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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