FDA 510(k)

Système de Cartographie ACORYS

Numéro K : K253861 · 2026-04-13

Date de décision2026-04-13

Code produitDQK

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

ACORYS MAPPING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Corify Care S.L. It received FDA 510(k) clearance on 2026-04-13 under 510(k) number K253861. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the ACORYS MAPPING SYSTEM?

ACORYS MAPPING SYSTEM is a medical device that received FDA 510(k) clearance on 2026-04-13. The listed applicant is Corify Care S.L. The 510(k) number is K253861.

When did ACORYS MAPPING SYSTEM receive FDA 510(k) clearance?

ACORYS MAPPING SYSTEM received FDA 510(k) clearance on 2026-04-13, under 510(k) number K253861.

Who is the listed applicant for ACORYS MAPPING SYSTEM?

The FDA 510(k) record lists Corify Care S.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACORYS MAPPING SYSTEM?

The FDA product code for ACORYS MAPPING SYSTEM is DQK.

Essais cliniques associés

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Dispositifs connexes (Code : DQK)

K261729EnSite™ X EP SystemAbbott Medical K262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston Scientific K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott Medical K252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

Source officielle

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