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FDA 510(k)

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip

K-Number: K160454 · 2016-03-18

ApplicantAtriCure, Inc.
Decision Date2016-03-18
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip is a medical device manufactured by AtriCure, Inc.. It received FDA 510(k) clearance on 2016-03-18 under approval number K160454. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip?

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip is a medical device that received FDA 510(k) clearance on 2016-03-18. It is manufactured by AtriCure, Inc.. The 510(k) number is K160454.

When was AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip approved by the FDA?

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip received FDA 510(k) clearance on 2016-03-18, under approval number K160454.

What company makes AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip?

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip is manufactured by AtriCure, Inc..

What is the FDA product code for AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip?

The FDA product code for AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip is FZP.

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Other Devices by AtriCure, Inc.

K152337cryoFORM cryoICE cryoablation probe 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 K163408Isolator Multifunctional Linear Pen

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Related Devices (Code: FZP)

K161758Weck Auto Endo10 Automatic Endoscopic Clip ApplierTeleflex Medical K151943Vas-Q-ClipNanova Biomaterials, Inc. K152082Vesocclude Polymer Ligating ClipVesocclude Medical, LLC K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipAtriCure, Inc. K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc. K172742AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)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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