Japan PMDA registration 381005_30300BZX00337000_A_01_03

TactiFlex SE Irrigation Catheter

JP: TactiFlex SE イリゲーションカテーテル
Japan flagJapan·MD·A5100·Updated July 11, 2022
Intended use / 使用目的
English
For < intended use> this product is a catheter that performs percutaneous catheter myocardial ablation and cardiac electrophysiological examination by high-frequency current for the treatment of symptomatic paroxysmal and persistent atrial fibrillation and normal atrial flutter refractory to drug treatment.
日本語 (Japanese)
<使用目的>本品は、薬物治療抵抗性の有症候性の発作性及び持続性心房細動、通常型心房粗動の治療を目的に、高周波電流による経皮的カテーテル心筋焼灼術および心臓電気生理学的検査を実施するカテーテルである。
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
381005_30300BZX00337000_A_01_03
Last Update Date
July 11, 2022
Official Documents
View PDF (PMDA)
Manufacturer / 製造販売業者
日本語 (Japanese)
製造販売/アボットメディカルジャパン合同会社
About this record

Access comprehensive regulatory information for TactiFlex SE Irrigation Catheter (TactiFlex SE イリゲーションカテーテル) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 381005_30300BZX00337000_A_01_03 and manufactured by Manufacture and sales / Abbott Medical Japan G.K.. The device information was last updated on July 11, 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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