FDA 510(k)

斯提萊托延長停留式心臟导管

K 號：K210047 · 2021-08-27

決定日期2021-08-27

產品代碼PND

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Stiletto Extended Dwell Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Piper Access, LLC. It received FDA 510(k) clearance on 2021-08-27 under 510(k) number K210047. The device is classified under product code PND. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Stiletto Extended Dwell Catheter?

Stiletto Extended Dwell Catheter is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is Piper Access, LLC. The 510(k) number is K210047.

When did Stiletto Extended Dwell Catheter receive FDA 510(k) clearance?

Stiletto Extended Dwell Catheter received FDA 510(k) clearance on 2021-08-27, under 510(k) number K210047.

Who is the listed applicant for Stiletto Extended Dwell Catheter?

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

What is the FDA product code for Stiletto Extended Dwell Catheter?

The FDA product code for Stiletto Extended Dwell Catheter is PND.

其他以 Piper Access, 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。

K191976Piper GO-IO 骨內輸液系統 K1819045 FR雙腔道皮克PICC

相關器械（代碼：PND）

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。

K252402中線心导管Terumo Medical Products (Hangzhou) Co., Ltd.K213855Arrow 壓力注射中線針Arrow International, LLC Subsidiary of Teleflex Incorporated K213203證誠™ 中間導管C.R. Bard, Inc.K192802primeMidline 靜脈針管Pfm Medical, Inc.K181208維瓊中線3F SL 腹腔鏈條導管；維瓊中線4F SL 腹腔鏈條導管；維瓊中線5F DL 腹腔鏈條導管Vygon USA K173114primeMidline 靜脈針管Pfm Medical, Inc.

官方來源

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