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FDA 510(k)

EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License

K-Number: K201148 · 2020-06-26

ApplicantABBOTT MEDICAL
Decision Date2020-06-26
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2020-06-26 under 510(k) number K201148. 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 Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License?

EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License is a medical device that received FDA 510(k) clearance on 2020-06-26. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K201148.

When did EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License receive FDA 510(k) clearance?

EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License received FDA 510(k) clearance on 2020-06-26, under 510(k) number K201148.

Who is the listed applicant for EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License?

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

What is the FDA product code for EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License?

The FDA product code for EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License 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.

NCT01254474Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential CatheterCOMPLETEDNCT07421076Grid eXplore Mapping StudyRECRUITINGNCT07699783Transcranial Ultrasound Stimulation for Tourette SyndromeNOT_YET_RECRUITINGNCT07746336Treatment Based on High Precision Cardiac MappingRECRUITING

Other records listing ABBOTT MEDICAL as applicant

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PMA P910023Implantable cardioverter defibrillator (non-CRT)PMA P160054Ventricular (assist) bypassPMA P060040Ventricular (assist) bypassPMA P030054Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)PMA P250022Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible ElectroporationPMA P040021heart-valve, non-allograft tissue

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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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