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FDA 510(k)

EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter

K-Number: K210313 · 2022-12-30

ApplicantShanghai Microport EP Medtech Co., Ltd.
Decision Date2022-12-30
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter is a medical device manufactured by Shanghai Microport EP Medtech Co., Ltd.. It received FDA 510(k) clearance on 2022-12-30 under approval number K210313. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter?

EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter is a medical device that received FDA 510(k) clearance on 2022-12-30. It is manufactured by Shanghai Microport EP Medtech Co., Ltd.. The 510(k) number is K210313.

When was EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter approved by the FDA?

EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter received FDA 510(k) clearance on 2022-12-30, under approval number K210313.

What company makes EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter?

EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter is manufactured by Shanghai Microport EP Medtech Co., Ltd..

What is the FDA product code for EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter?

The FDA product code for EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter is DRF.

Related Clinical Trials

NCT01254474 Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter COMPLETED NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT05225935 Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia COMPLETED NCT07308847 Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360) RECRUITING NCT06808217 A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation ACTIVE_NOT_RECRUITING

Other Devices by Shanghai Microport EP Medtech Co., Ltd.

K212625PathBuilder Transseptal Needle K212626PathBuilder Transseptal Guiding Introducer K211530PathBuilder Steerable Introducer

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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