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FDA 510(k)

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2

K-Number: K183128 · 2018-12-12

ApplicantAbbott
Decision Date2018-12-12
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott. It received FDA 510(k) clearance on 2018-12-12 under 510(k) number K183128. 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 EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2?

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 is a medical device that received FDA 510(k) clearance on 2018-12-12. The listed applicant is Abbott. The 510(k) number is K183128.

When did EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 receive FDA 510(k) clearance?

EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 received FDA 510(k) clearance on 2018-12-12, under 510(k) number K183128.

Who is the listed applicant for EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2?

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

What is the FDA product code for EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2?

The FDA product code for EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 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.

NCT029806144D Velocity Mapping of the Heart in rTOF PatientsCOMPLETEDNCT07746336Treatment Based on High Precision Cardiac MappingNOT_YET_RECRUITING

Other records listing Abbott as applicant

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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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