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FDA 510(k)

Atrial Fibrillation History Feature

K-Number: K213971 · 2022-06-03

ApplicantApple, Inc.
Decision Date2022-06-03
Product CodeQDB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Atrial Fibrillation History Feature is a medical device manufactured by Apple, Inc.. It received FDA 510(k) clearance on 2022-06-03 under approval number K213971. The device is classified under product code QDB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Atrial Fibrillation History Feature?

Atrial Fibrillation History Feature is a medical device that received FDA 510(k) clearance on 2022-06-03. It is manufactured by Apple, Inc.. The 510(k) number is K213971.

When was Atrial Fibrillation History Feature approved by the FDA?

Atrial Fibrillation History Feature received FDA 510(k) clearance on 2022-06-03, under approval number K213971.

What company makes Atrial Fibrillation History Feature?

Atrial Fibrillation History Feature is manufactured by Apple, Inc..

What is the FDA product code for Atrial Fibrillation History Feature?

The FDA product code for Atrial Fibrillation History Feature is QDB.

Related Clinical Trials

NCT01254474 Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter COMPLETED NCT06170606 POLARx Post Approval Study (POLARx PAS) ACTIVE_NOT_RECRUITING NCT07187115 A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT07444320 Evaluation of Novel Waveforms Delivered Using the FARAPULSE™ PFA System RECRUITING NCT07601763 Pulsed Field Ablation Outcomes With Efficacy and Randomization in Atrial Fibrillation (POWER-AF) RECRUITING

Related PubMed Literature

PMID: 40714034 Relationship between industry payments to physicians and prescription patterns for PCSK9is, ARNis and DOACs: A report from the NCDR PINNACLE registry. American heart journal (2026)

Other Devices by Apple, Inc.

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Related Devices (Code: QDB)

DEN180042Irregular Rhythm Notification FeatureApple, Inc. K212516IRNF AppApple, Inc. K212372Fitbit Irregular Rhythm NotificationsFitbit, Inc. K231173Irregular Rhythm Notification Feature (IRNF)Apple, 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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