TactiFlex SE Irrigation Catheter - PMDA ID 381005_30300BZX00337000_A_01_03
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.
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.
＜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。