FDA 510(k)

MIVI 6F 25cm Mi-EXT エクステンションカテーテル、MIVI 5F 25cm Mi-EXT エクステンションカテーテル、MIVI 4F 30cm Mi-EXT エクステンションカテーテル、MIVI 3F 43cm Mi-EXT エクステンションカテーテル

K番号: K163233 · 2017-04-06

決定日2017-04-06

製品コードDQY

諮問委員会以下は、提供された医療機器規制テキストの日本語訳です。 --- **政策：medical-regulatory-v1** --- [ここに原文が記載されています] --- **会社名/製品名**：[ここに会社名または製品名が記載されています] **FDA**：食品医薬品局 **510(k)**：510(k)届出 **PMA**：プレマーケティング評価届出 **NCT**：臨床試験登録番号 **PMID**：PubMed ID **識別子**：[ここに識別子が記載されています] **URL**：[ここにURLが記載されています]

決定大幅同等

医療機器の概要

MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Mivi Neuroscience, Inc.. It received FDA 510(k) clearance on 2017-04-06 under 510(k) number K163233. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter?

MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter is a medical device that received FDA 510(k) clearance on 2017-04-06. The listed applicant is Mivi Neuroscience, Inc.. The 510(k) number is K163233.

When did MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter receive FDA 510(k) clearance?

MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter received FDA 510(k) clearance on 2017-04-06, under 510(k) number K163233.

Who is the listed applicant for MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter?

The FDA 510(k) record lists Mivi Neuroscience, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter?

The FDA product code for MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter is DQY.

申請者としてMivi Neuroscience, Inc.を記載するその他の記録

K222948遠位アクセスカテーテル K212402MIVI Q 遠位アクセスカテーテル

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