Cleared Traditional

EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter

K210313 · Shanghai Microport EP Medtech Co., Ltd. · Cardiovascular

Dec 2022

Decision

695d

Days

Class 2

Risk

About This 510(k) Submission

K210313 is an FDA 510(k) clearance for the EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter, a Catheter, Electrode Recording, Or Probe, Electrode Recording (Class II — Special Controls, product code DRF), submitted by Shanghai Microport EP Medtech Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on December 30, 2022, 695 days after receiving the submission on February 3, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number	K210313 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 03, 2021
Decision Date	December 30, 2022
Days to Decision	695 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DRF — Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1220