SLEUTH IMPLANTABLE ECG MONITORING SYSTEM— 510(k) K063035

Name: FDA 510(k) clearance K063035
Creator: U.S. Food and Drug Administration
Published: 2007-10-01

Substantially Equivalent

Transnoma Medical, Inc.

FDA 510(k) clearance K063035 for SLEUTH IMPLANTABLE ECG MONITORING SYSTEM, Substantially Equivalent on 2007-10-01. Applicant: Transnoma Medical, Inc.. Device class: 2.

Clearance details

Applicant: Transnoma Medical, Inc.
Product code: Code MXC
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2006-09-29
Decision date: 2007-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arden Hills, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MXC

view all

K230286 — Assert-IQ Insertable Cardiac Monitor2023-05-17
K212206 — Jot Dx Insertable Cardiac Monitor2021-08-13
K202876 — Confirm Rx Insertable Cardiac Monitor2020-12-01
K202888 — Confirm Rx Insertable Cardiac Monitor2020-11-23
K193310 — myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)2020-03-17

Adverse events under product code MXC

product code MXC

Death: 4
Injury: 758
Malfunction: 5,066
Total: 5,828

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.