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FDA 510(k)

AtriClip LAA Exclusion System

K-Number: K210293 · 2021-03-03

ApplicantAtriCure, Inc.
Decision Date2021-03-03
Product CodePZX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AtriClip LAA Exclusion System is a medical device manufactured by AtriCure, Inc.. It received FDA 510(k) clearance on 2021-03-03 under approval number K210293. 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 AtriClip LAA Exclusion System?

AtriClip LAA Exclusion System is a medical device that received FDA 510(k) clearance on 2021-03-03. It is manufactured by AtriCure, Inc.. The 510(k) number is K210293.

When was AtriClip LAA Exclusion System approved by the FDA?

AtriClip LAA Exclusion System received FDA 510(k) clearance on 2021-03-03, under approval number K210293.

What company makes AtriClip LAA Exclusion System?

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

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

The FDA product code for AtriClip 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)

K181474ArtiClip LAA Exclusion SystemAtriCure, Inc. K191413AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-ClipAtriCure, 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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