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FDA 510(k)

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)

K-Number: K172742 · 2017-10-11

ApplicantAtriCure, Inc.
Decision Date2017-10-11
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2) is a medical device manufactured by AtriCure, Inc.. It received FDA 510(k) clearance on 2017-10-11 under approval number K172742. 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 (PRO2)?

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2) is a medical device that received FDA 510(k) clearance on 2017-10-11. It is manufactured by AtriCure, Inc.. The 510(k) number is K172742.

When was AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2) approved by the FDA?

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2) received FDA 510(k) clearance on 2017-10-11, under approval number K172742.

What company makes AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)?

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2) is manufactured by AtriCure, Inc..

What is the FDA product code for AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)?

The FDA product code for AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2) is FZP.

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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 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. K160454AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, 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.

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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