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FDA 510(k)

MediGuide Technology System

K-Number: K162643 · 2016-12-13

ApplicantSt Jude Medical
Decision Date2016-12-13
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MediGuide Technology System is a medical device manufactured by St Jude Medical. It received FDA 510(k) clearance on 2016-12-13 under approval number K162643. 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 MediGuide Technology System?

MediGuide Technology System is a medical device that received FDA 510(k) clearance on 2016-12-13. It is manufactured by St Jude Medical. The 510(k) number is K162643.

When was MediGuide Technology System approved by the FDA?

MediGuide Technology System received FDA 510(k) clearance on 2016-12-13, under approval number K162643.

What company makes MediGuide Technology System?

MediGuide Technology System is manufactured by St Jude Medical.

What is the FDA product code for MediGuide Technology System?

The FDA product code for MediGuide Technology System is DQK.

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Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025) PMID: 40837401 Mining and evaluation of security alert signals of neuroprotective agents based on the Jinan adverse event reporting system database: a retrospective study. Frontiers in pharmacology (2025) PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by St Jude Medical

K160218AutoMark Module K160210EnSite Precision Cardiac Mapping System v2.0 K160335Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D K161873Pacel Flow Directed Pacing Catheter K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0 K160186EnSite Velocity Surface Electrode Kit

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Related Devices (Code: DQK)

K160218AutoMark ModuleSt Jude Medical K160210EnSite Precision Cardiac Mapping System v2.0St Jude Medical K162440CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc. K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0St Jude Medical K160186EnSite Velocity Surface Electrode KitSt 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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