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FDA 510(k)

Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)

K-Number: K233943 · 2024-03-08

ApplicantMedtronic, Inc.
Decision Date2024-03-08
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013) is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2024-03-08 under approval number K233943. 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 Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)?

Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013) is a medical device that received FDA 510(k) clearance on 2024-03-08. It is manufactured by Medtronic, Inc.. The 510(k) number is K233943.

When was Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013) approved by the FDA?

Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013) received FDA 510(k) clearance on 2024-03-08, under approval number K233943.

What company makes Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)?

Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013) is manufactured by Medtronic, Inc..

What is the FDA product code for Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)?

The FDA product code for Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013) is DQK.

Related Clinical Trials

NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING

Related PubMed Literature

PMID: 41608759 Collaborative and Cooperative Hospital "In-House" Medical Device Development and Implementation in the AI Age: The European Responsible AI Development (EURAID) Framework Compatible With European Values. Journal of medical Internet research (2026)

Other Devices by Medtronic, Inc.

K162896Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface K162892Achieve Advance Mapping Catheter K162054Medtronic Temporary External Pacemaker 53401 K162550Medtronic Model 5392 External Pulse Generator (EPG) K162016Affinity NT Oxygenator with Cortiva BioActive Surface K160983Kyphon HV-R Bone Cement

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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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