Japan PMDA registration 530366_22600BZX00062000_B_01_06

Accessory manual retraction kit for "Arctic Front Advance Cryoablation Catheter"

JP: 『Arctic Front Advance冷凍アブレーションカテーテル』の付属品 マニュアルリトラクションキット
Japan flagJapan·MD·A5100·Updated October 01, 2022
Intended use / 使用目的
English
1. This product is used to manually decompress the balloon when it has not deflated even after a series of operations using the console have been completed.
日本語 (Japanese)
1. 本品は、コンソールを用いた一連の操作が終了した後もバルーンが収縮していない場合に、手動でバルーンを収縮させるために使用するものである。
Device classification / 分類
Device Type
MD
Device Class
A5100
Class Name (English)
Cardiac Catheter for Ablation
Class Name (日本語)
アブレーション向け循環器用カテーテル
Registration information / 登録情報
PMDA ID
530366_22600BZX00062000_B_01_06
Last Update Date
October 01, 2022
Official Documents
View PDF (PMDA)
Manufacturer / 製造販売業者
日本語 (Japanese)
製造販売/日本メドトロニック株式会社
About this record

Access comprehensive regulatory information for Accessory manual retraction kit for "Arctic Front Advance Cryoablation Catheter" (『Arctic Front Advance冷凍アブレーションカテーテル』の付属品 マニュアルリトラクションキット) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 530366_22600BZX00062000_B_01_06 and manufactured by Medtronic Japan Co., Ltd.. The device information was last updated on October 01, 2022.

This page provides complete registration details including device class (A5100), classification (Cardiac Catheter for Ablation / アブレーション向け循環器用カテーテル), manufacturer information (English and Japanese), intended use, and regulatory compliance data from the official Japan PMDA medical device database. Pure Global AI offers free bilingual access to Japan's complete medical device registry, helping global MedTech companies navigate PMDA regulations efficiently.

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