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CareLink SmartSync Device Manager Pacing System Analyzer

by Medtronic, Inc.

510(k) K163008

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK163008 Date28 Feb 2017ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DTA
Device Class
Class II
Regulation
21 CFR Part 870.3720
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The CareLink SmartSync Device Manager is a microprocessor-based pacing system analyzer used during cardiac device implantation or invasive troubleshooting. It functions as a tester for pacemaker electrode function and allows clinicians to make programming changes to implantable devices.

The system consists of a downloadable app, a patient connector, a base, and an Apple iPad. It is intended for use in the operating suite or follow-up clinic settings. This device has received FDA 510k clearance.

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