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FDA 510(k)

Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0

K-Number: K160187 · 2016-10-21

ApplicantSt Jude Medical
Decision Date2016-10-21
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2016-10-21 under 510(k) number K160187. 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 v5.0, Ensite Automap Module v1.0?

Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 is a medical device that received FDA 510(k) clearance on 2016-10-21. The listed applicant is St Jude Medical. The 510(k) number is K160187.

When did Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 receive FDA 510(k) clearance?

Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 received FDA 510(k) clearance on 2016-10-21, under 510(k) number K160187.

Who is the listed applicant for Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0?

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

What is the FDA product code for Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0?

The FDA product code for Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 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 PatientsCOMPLETED

Other records listing St Jude Medical as applicant

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.

PMA P960016Cardiac ablation percutaneous catheterPMA P130026Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillationK181382GuardianTM Burr Hole Cover SystemK172396EnSite Velocity Cardiac Mapping System v5.2K172393Advisor HD Grid Mapping Catheter, Sensor EnabledK173232myMerlin(TM) Mobile Application Model APP1001

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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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