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FDA 510(k)

Vektor Computational ECG Mapping System (vMap®)

K-Number: K252429 · 2025-12-04

ApplicantVektor Medical, Inc.
Decision Date2025-12-04
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vektor Computational ECG Mapping System (vMap®) is a medical device manufactured by Vektor Medical, Inc.. It received FDA 510(k) clearance on 2025-12-04 under approval number K252429. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vektor Computational ECG Mapping System (vMap®)?

Vektor Computational ECG Mapping System (vMap®) is a medical device that received FDA 510(k) clearance on 2025-12-04. It is manufactured by Vektor Medical, Inc.. The 510(k) number is K252429.

When was Vektor Computational ECG Mapping System (vMap®) approved by the FDA?

Vektor Computational ECG Mapping System (vMap®) received FDA 510(k) clearance on 2025-12-04, under approval number K252429.

What company makes Vektor Computational ECG Mapping System (vMap®)?

Vektor Computational ECG Mapping System (vMap®) is manufactured by Vektor Medical, Inc..

What is the FDA product code for Vektor Computational ECG Mapping System (vMap®)?

The FDA product code for Vektor Computational ECG Mapping System (vMap®) is DQK.

Related Clinical Trials

NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT07221565 Electromagnetic Immunotherapy Mapping and Cytokine Forecasting Study (QSIT) ENROLLING_BY_INVITATION NCT05225935 Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia COMPLETED

Related PubMed Literature

PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 33371797 Developing a Qualification and Verification Strategy for Digital Tissue Image Analysis in Toxicological Pathology. Toxicologic pathology (2021)

Other Devices by Vektor Medical, Inc.

K211546Vektor Computational ECG Mapping System (vMap)

Related Devices (Code: DQK)

K160218AutoMark ModuleSt Jude Medical K160210EnSite Precision Cardiac Mapping System v2.0St Jude Medical K162643MediGuide Technology SystemSt Jude Medical K162440CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc. K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0St Jude Medical K160186EnSite Velocity Surface Electrode KitSt Jude Medical

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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