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FDA 510(k)

EnSite Velocity Surface Electrode Kit

K-Number: K160186 · 2016-10-07

ApplicantSt Jude Medical
Decision Date2016-10-07
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EnSite Velocity Surface Electrode Kit is a medical device manufactured by St Jude Medical. It received FDA 510(k) clearance on 2016-10-07 under approval number K160186. 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 Surface Electrode Kit?

EnSite Velocity Surface Electrode Kit is a medical device that received FDA 510(k) clearance on 2016-10-07. It is manufactured by St Jude Medical. The 510(k) number is K160186.

When was EnSite Velocity Surface Electrode Kit approved by the FDA?

EnSite Velocity Surface Electrode Kit received FDA 510(k) clearance on 2016-10-07, under approval number K160186.

What company makes EnSite Velocity Surface Electrode Kit?

EnSite Velocity Surface Electrode Kit is manufactured by St Jude Medical.

What is the FDA product code for EnSite Velocity Surface Electrode Kit?

The FDA product code for EnSite Velocity Surface Electrode Kit is DQK.

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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 K153654Sentry WEB SmartInterpCarefusion Germany 234 GmbH

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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