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FDA 510(k)

AtriClip FLEX-V

K-Number: K180010 · 2018-01-31

ApplicantAtriCure, Inc.
Decision Date2018-01-31
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AtriClip FLEX-V is a medical device manufactured by AtriCure, Inc.. It received FDA 510(k) clearance on 2018-01-31 under approval number K180010. 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 FLEX-V?

AtriClip FLEX-V is a medical device that received FDA 510(k) clearance on 2018-01-31. It is manufactured by AtriCure, Inc.. The 510(k) number is K180010.

When was AtriClip FLEX-V approved by the FDA?

AtriClip FLEX-V received FDA 510(k) clearance on 2018-01-31, under approval number K180010.

What company makes AtriClip FLEX-V?

AtriClip FLEX-V is manufactured by AtriCure, Inc..

What is the FDA product code for AtriClip FLEX-V?

The FDA product code for AtriClip FLEX-V is FZP.

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: 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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