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FDA 510(k)

ArtiClip LAA Exclusion System

K-Number: K181474 · 2018-06-28

ApplicantAtriCure, Inc.
Decision Date2018-06-28
Product CodePZX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ArtiClip LAA Exclusion System is a medical device manufactured by AtriCure, Inc.. It received FDA 510(k) clearance on 2018-06-28 under approval number K181474. The device is classified under product code PZX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ArtiClip LAA Exclusion System?

ArtiClip LAA Exclusion System is a medical device that received FDA 510(k) clearance on 2018-06-28. It is manufactured by AtriCure, Inc.. The 510(k) number is K181474.

When was ArtiClip LAA Exclusion System approved by the FDA?

ArtiClip LAA Exclusion System received FDA 510(k) clearance on 2018-06-28, under approval number K181474.

What company makes ArtiClip LAA Exclusion System?

ArtiClip LAA Exclusion System is manufactured by AtriCure, Inc..

What is the FDA product code for ArtiClip LAA Exclusion System?

The FDA product code for ArtiClip LAA Exclusion System is PZX.

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Other Devices by AtriCure, Inc.

K152337cryoFORM cryoICE cryoablation probe K160454AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip K173031AtriClip LAA Exclusion System with Preloaded PRO·V Clip K172742AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2) K163261AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip

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Related Devices (Code: PZX)

K191413AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-ClipAtriCure, Inc. K210293AtriClip LAA Exclusion SystemAtriCure, Inc. K220305Syntheon LAA Exclusion System, Syntheon LAA Selection GuideSyntheon K233407AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (ACH2); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO1); AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2); AtriClip PRO-V LAA Exclusion System (PROV); AtriClip Flex-V LAA Exclusion System with preloaded V Clip (ACHV)AtriCure, Inc. K232295LAA Exclusion SystemSyntheon, LLC K234125AtriClip FLEX-Mini LAA Exclusion System (ACHM)AtriCure, 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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