REVEAL LINQ INSERTABLE CARDIAC MONITOR— 510(k) K132649

Name: FDA 510(k) clearance K132649
Creator: U.S. Food and Drug Administration
Published: 2014-02-14

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K132649 for REVEAL LINQ INSERTABLE CARDIAC MONITOR, Substantially Equivalent on 2014-02-14. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic, Inc.
Product code: Code MXD
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 2013-08-26
Decision date: 2014-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mounds View, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MXD

product code MXD

Injury: 1,880
Malfunction: 9,487
Total: 11,367

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K132649

K-number listed on FDA's recall record

Z-1249-2016 — Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous ECG continuously.Class II·Terminated·Medtronic Inc.·20160223

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132649.

Data sourced from openFDA. This site is unofficial and independent of the FDA.