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FDA 510(k)

Affera Integrated Mapping System

K-Number: K243892 · 2025-01-17

ApplicantMedtronic, Inc.
Decision Date2025-01-17
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Affera Integrated Mapping System is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2025-01-17 under approval number K243892. 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 Integrated Mapping System?

Affera Integrated Mapping System is a medical device that received FDA 510(k) clearance on 2025-01-17. It is manufactured by Medtronic, Inc.. The 510(k) number is K243892.

When was Affera Integrated Mapping System approved by the FDA?

Affera Integrated Mapping System received FDA 510(k) clearance on 2025-01-17, under approval number K243892.

What company makes Affera Integrated Mapping System?

Affera Integrated Mapping System is manufactured by Medtronic, Inc..

What is the FDA product code for Affera Integrated Mapping System?

The FDA product code for Affera Integrated Mapping System is DQK.

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Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

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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