510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063035Substantially Equivalent

Sleuth Implantable ECG Monitoring System

Transnoma Medical, Inc., Arden Hills MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063035 is the FDA 510(k) clearance record for SLEUTH IMPLANTABLE ECG MONITORING SYSTEM, a class II device, cleared for Transnoma Medical, Inc. on under FDA product code MXC (Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)). FDA records list one 510(k) clearance for Transnoma Medical, Inc. As of , FDA records show no recalls naming K063035.

Clearance record

Decision date
Received
(367 days to decision)
Product code
MXC Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Regulation
21 CFR 870.2800
Device class
Class II
Review panel
Cardiovascular
Applicant
Transnoma Medical, Inc. 4358 W. Round Lake Rd., Arden Hills MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MXC

Trailing 12 months

FDA records hold no clearances under product code MXC in the trailing twelve months.

FDA records show no clearances under product code MXC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MXC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260