Medical Device Manufacturer · US , Burlington , MA

Rhythmia Medical, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2013

Recent clearances: IntellaMap Orion High Resolution Mapping Catheter, RHYTHMIA MAPPING SYSTEM, RHYTHMIA MAPPING CATHETER

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Rhythmia Medical, Inc. Cardiovascular ✕

3 devices

1-3 of 3

Cleared Jan 08, 2015

IntellaMap Orion High Resolution Mapping Catheter

Cardiovascular · 31d

Cleared CT Jul 22, 2013

RHYTHMIA MAPPING SYSTEM

Cardiovascular · 125d

Cleared Apr 18, 2013

RHYTHMIA MAPPING CATHETER

Cardiovascular · 248d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 17, 2026