REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528— 510(k) K103764

Name: FDA 510(k) clearance K103764
Creator: U.S. Food and Drug Administration
Published: 2011-05-04

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K103764 for REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528, Substantially Equivalent on 2011-05-04. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic, Inc.
Product code: Code DSI
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 2010-12-23
Decision date: 2011-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mounds View, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DSI

view all

K243349 — BodyGuardian Remote Monitoring System (BGRMS v3.0)2026-01-23
K250356 — MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)2025-07-29
K240177 — Zio AT® device (A100A1001)2024-10-30
K230265 — MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System2023-10-06
K231276 — SmartCardia 7L Platform2023-08-30

More clearances from Medtronic, Inc.

view all

K262735 — LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)2026-08-28
K262005 — Affera Integrated Mapping System2026-08-21
K261335 — VitalFlow Set with Balance Biosurface2026-07-31
K261866 — Concerto Versa Detachable Coil2026-06-24
K260195 — Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae2026-04-23

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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 →

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