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FDA 510(k)

LAA Exclusion System

K-Number: K232295 · 2023-08-30

ApplicantSyntheon, LLC
Decision Date2023-08-30
Product CodePZX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LAA Exclusion System is a medical device manufactured by Syntheon, LLC. It received FDA 510(k) clearance on 2023-08-30 under approval number K232295. 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 LAA Exclusion System?

LAA Exclusion System is a medical device that received FDA 510(k) clearance on 2023-08-30. It is manufactured by Syntheon, LLC. The 510(k) number is K232295.

When was LAA Exclusion System approved by the FDA?

LAA Exclusion System received FDA 510(k) clearance on 2023-08-30, under approval number K232295.

What company makes LAA Exclusion System?

LAA Exclusion System is manufactured by Syntheon, LLC.

What is the FDA product code for LAA Exclusion System?

The FDA product code for LAA Exclusion System is PZX.

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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. 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. 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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