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FDA 510(k)

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip

K-Number: K191413 · 2019-08-21

ApplicantAtriCure, Inc.
Decision Date2019-08-21
Product CodePZX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip is a medical device manufactured by AtriCure, Inc.. It received FDA 510(k) clearance on 2019-08-21 under approval number K191413. 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 with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip?

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip is a medical device that received FDA 510(k) clearance on 2019-08-21. It is manufactured by AtriCure, Inc.. The 510(k) number is K191413.

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

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip received FDA 510(k) clearance on 2019-08-21, under approval number K191413.

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

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

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

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