FDA 510(k)

LAA Exclusion System

Numéro K : K232295 · 2023-08-30

Date de décision2023-08-30

Code produitPZX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

LAA Exclusion System is the device name listed in this FDA 510(k) record. The listed applicant is Syntheon, LLC. It received FDA 510(k) clearance on 2023-08-30 under 510(k) number K232295. The device is classified under product code PZX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the LAA Exclusion System?

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

When did LAA Exclusion System receive FDA 510(k) clearance?

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

Who is the listed applicant for LAA Exclusion System?

The FDA 510(k) record lists Syntheon, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAA Exclusion System?

The FDA product code for LAA Exclusion System is PZX.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Dispositifs connexes (Code : PZX)

K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150)Edwards Lifesciences K252917ATLAAS (Système Appendage Atrial Gauche Atraumatique) (AD)Genesee Biomedical, Inc.K243860AtriClip PRO-Mini LAA Exclusion System (PROM)AtriCure, Inc.K234125AtriClip FLEX-Mini LAA Exclusion System (ACHM)AtriCure, Inc.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.K220305Syntheon LAA Exclusion System, Syntheon LAA Selection GuideSyntheon

Source officielle

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