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FDA 510(k)

Affera Integrated Mapping System; Impedance Localization Patch Kit

K-Number: K241828 · 2024-11-01

ApplicantMedtronic, Inc.
Decision Date2024-11-01
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Affera Integrated Mapping System; Impedance Localization Patch Kit is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2024-11-01 under 510(k) number K241828. 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; Impedance Localization Patch Kit?

Affera Integrated Mapping System; Impedance Localization Patch Kit is a medical device that received FDA 510(k) clearance on 2024-11-01. The listed applicant is Medtronic, Inc.. The 510(k) number is K241828.

When did Affera Integrated Mapping System; Impedance Localization Patch Kit receive FDA 510(k) clearance?

Affera Integrated Mapping System; Impedance Localization Patch Kit received FDA 510(k) clearance on 2024-11-01, under 510(k) number K241828.

Who is the listed applicant for Affera Integrated Mapping System; Impedance Localization Patch Kit?

The FDA 510(k) record lists Medtronic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Affera Integrated Mapping System; Impedance Localization Patch Kit?

The FDA product code for Affera Integrated Mapping System; Impedance Localization Patch Kit is DQK.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT00271180Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy ProductsRECRUITINGNCT07005232Lead Evaluation for Defibrillation and Reliability Post Approval StudyENROLLING_BY_INVITATIONNCT07746336Treatment Based on High Precision Cardiac MappingRECRUITINGNCT07789925Sphere-9 PAF China StudyNOT_YET_RECRUITING

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Related Devices (Code: DQK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.

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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