FDA.reportPublic FDA data

510(k) K210313

Device
EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter
Applicant
Shanghai Microport EP Medtech Co., Ltd.
510(k) number
K210313
Product code
DRF
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-30
Date received
2021-02-03
Regulation
870.1220
Classification name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Xia Tian
Address
Bldg. 23&28, Ln. 588, Tianxiong Rd. Shanghai CN 201318 201318

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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