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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 the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2016-12-13 under 510(k) 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. The listed applicant is St Jude Medical. The 510(k) number is K162643.

When did MediGuide Technology System receive FDA 510(k) clearance?

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

Who is the listed applicant for MediGuide Technology System?

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 MediGuide Technology System?

The FDA product code for MediGuide Technology System is DQK.

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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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