Pure Global

FKD Atrial Septal RF Needle - PMDA ID 670053_30200BZX00388000_A_01_01

FKD心房中隔用RFニードル

Access comprehensive regulatory information for FKD Atrial Septal RF Needle (FKD心房中隔用RFニードル) in the Japan medical device market through Pure Global AI's free bilingual database. This MD medical device is registered under PMDA ID 670053_30200BZX00388000_A_01_01 and manufactured by Manufacture and sales/Fukuda Denshi Co., Ltd.. The device information was last updated on May 06, 2021.

This page provides complete registration details including device class (A5100), classification (Active puncture device for septum / 経中隔用能動型穿刺器具), 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.

Free Database
Powered by Pure Global AI
PMDA Official Data
Bilingual (EN/JP)
MD
A5100
670053_30200BZX00388000_A_01_01
MD
A5100
FKD Atrial Septal RF Needle
FKD心房中隔用RFニードル
PMDA ID: 670053_30200BZX00388000_A_01_01
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Use / 使用目的
English

This product is used when preparing an atrial septal foramen for inserting a catheter or the like from the right atrium into the left atrium in a transatrial septal wall. 1/2RF Needle

日本語 (Japanese)

本品は、経心房中隔壁的にカテーテル等を右房から左房に挿入するための心房中隔孔を作製する場合に使用する。1/2RF ニードル

Device Classification / 分類
Device Type
MD
Device Class
A5100
Class Name (English)
Active puncture device for septum
Class Name (日本語)
経中隔用能動型穿刺器具
Registration Information / 登録情報
PMDA ID
670053_30200BZX00388000_A_01_01
Last Update Date
May 06, 2021
Official Documents
Manufacturer / 製造販売業者
日本語 (Japanese)
製造販売/フクダ電子株式会社
Product Names / 製品名
Market Name (English)
FKD Atrial Septal RF Needle
Market Name (日本語)
FKD心房中隔用RFニードル