Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Catheter, Electrode Recording, Or Probe, Electrode Recording
510(k) Number K210313
Device Name EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter
Applicant
Shanghai Microport EP Medtech Co., Ltd.
Bldg. 23&28, Ln. 588, Tianxiong Rd.
Shanghai,  CN 201318
Applicant Contact Xia Tian
Correspondent
Shanghai Microport EP Medtech Co., Ltd.
Bldg. 23&28, Ln. 588, Tianxiong Rd.
Shanghai,  CN 201318
Correspondent Contact Min Zhu
Regulation Number870.1220
Classification Product Code
DRF  
Date Received02/03/2021
Decision Date 12/30/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-