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FDA 510(k)

CareLink SmartSync Device Manager - Pacing System Analyzer

K-Number: K163008 · 2017-02-28

ApplicantMedtronic, Inc.
Decision Date2017-02-28
Product CodeDTA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CareLink SmartSync Device Manager - Pacing System Analyzer is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2017-02-28 under approval number K163008. The device is classified under product code DTA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CareLink SmartSync Device Manager - Pacing System Analyzer?

CareLink SmartSync Device Manager - Pacing System Analyzer is a medical device that received FDA 510(k) clearance on 2017-02-28. It is manufactured by Medtronic, Inc.. The 510(k) number is K163008.

When was CareLink SmartSync Device Manager - Pacing System Analyzer approved by the FDA?

CareLink SmartSync Device Manager - Pacing System Analyzer received FDA 510(k) clearance on 2017-02-28, under approval number K163008.

What company makes CareLink SmartSync Device Manager - Pacing System Analyzer?

CareLink SmartSync Device Manager - Pacing System Analyzer is manufactured by Medtronic, Inc..

What is the FDA product code for CareLink SmartSync Device Manager - Pacing System Analyzer?

The FDA product code for CareLink SmartSync Device Manager - Pacing System Analyzer is DTA.

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Other Devices by Medtronic, Inc.

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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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