FDA 510(k)

SecurePortIV 腔管固定膠粘劑

K 號：K170505 · 2017-09-29

決定日期2017-09-29

產品代碼NZP

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

SecurePortIV Catheter Securement Adhesive is the device name listed in this FDA 510(k) record. The listed applicant is Adhezion Biomedical, LLC. It received FDA 510(k) clearance on 2017-09-29 under 510(k) number K170505. The device is classified under product code NZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SecurePortIV Catheter Securement Adhesive?

SecurePortIV Catheter Securement Adhesive is a medical device that received FDA 510(k) clearance on 2017-09-29. The listed applicant is Adhezion Biomedical, LLC. The 510(k) number is K170505.

When did SecurePortIV Catheter Securement Adhesive receive FDA 510(k) clearance?

SecurePortIV Catheter Securement Adhesive received FDA 510(k) clearance on 2017-09-29, under 510(k) number K170505.

Who is the listed applicant for SecurePortIV Catheter Securement Adhesive?

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

What is the FDA product code for SecurePortIV Catheter Securement Adhesive?

The FDA product code for SecurePortIV Catheter Securement Adhesive is NZP.

其他以 Adhezion Biomedical, LLC 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。

K223669SecurePortIV 高級導管固定膠粘劑 K161011SURGISEAL 局部皮膚膠粘劑，SURGISEAL Stylus 局部皮膚膠粘劑，SURGISEAL Twist 局部皮膚膠粘劑

相關器械（代碼：NZP）

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。

K223669SecurePortIV 高級導管固定膠粘劑Adhezion Biomedical, LLC

官方來源

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