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FDA 510(k)

Emprint Ablation System

K-Number: K163105 · 2016-12-06

ApplicantCovidien, LLC
Decision Date2016-12-06
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Emprint Ablation System is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2016-12-06 under approval number K163105. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Emprint Ablation System?

Emprint Ablation System is a medical device that received FDA 510(k) clearance on 2016-12-06. It is manufactured by Covidien, LLC. The 510(k) number is K163105.

When was Emprint Ablation System approved by the FDA?

Emprint Ablation System received FDA 510(k) clearance on 2016-12-06, under approval number K163105.

What company makes Emprint Ablation System?

Emprint Ablation System is manufactured by Covidien, LLC.

What is the FDA product code for Emprint Ablation System?

The FDA product code for Emprint Ablation System is NEY.

Related Clinical Trials

NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT06762717 FARAPULSE™ Pulsed Field Ablation System RECRUITING NCT06170606 POLARx Post Approval Study (POLARx PAS) ACTIVE_NOT_RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING NCT07523620 Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration RECRUITING

Related PubMed Literature

PMID: 36632328 Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation. JAMIA open (2023)

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Related Devices (Code: NEY)

K160141miraDry SystemMiramar Labs, Inc. K160936Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc. K171358Emprint SX Ablation Platform and AccessoriesCoviden, LLC K162449Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm)AngioDynamics, Inc. K163118FLEX Microwave Ablation System and AccessoriesNeuwave Medical, Inc. K173756Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc.

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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