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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 the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2017-02-28 under 510(k) 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. The listed applicant is Medtronic, Inc.. The 510(k) number is K163008.

When did CareLink SmartSync Device Manager - Pacing System Analyzer receive FDA 510(k) clearance?

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

Who is the listed applicant for CareLink SmartSync Device Manager - Pacing System Analyzer?

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

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.

Related Clinical Trials

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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