FDA 510(k)

LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System

K-Number: K210484 · 2021-06-11

Decision Date2021-06-11

Product CodeMXD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2021-06-11 under 510(k) number K210484. The device is classified under product code MXD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System?

LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System is a medical device that received FDA 510(k) clearance on 2021-06-11. The listed applicant is Medtronic, Inc.. The 510(k) number is K210484.

When did LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System receive FDA 510(k) clearance?

LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System received FDA 510(k) clearance on 2021-06-11, under 510(k) number K210484.

Who is the listed applicant for LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System?

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 LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System?

The FDA product code for LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System is MXD.

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Related Devices (Code: MXD)

K261074BIOMONITOR IV (471155)Biotronik, Inc.K253516Assert-IQ (DM5100)ABBOTT MEDICAL K251221Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)Abbott K252593LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)Boston Scientific Corporation K240693LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc.K233562LINQ II Insertable Cardiac MonitorMedtronic, Inc.

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.