510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K143481Substantially Equivalent

IntellaMap Orion High Resolution Mapping Catheter

Rhythmia Medical, Inc., Burlington MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K143481 is the FDA 510(k) clearance record for IntellaMap Orion High Resolution Mapping Catheter, a class II device, cleared for Rhythmia Medical, Inc. on under FDA product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording). FDA records list 3 510(k) clearances for Rhythmia Medical, Inc., from to . As of , FDA records show no recalls naming K143481.

Clearance record

Decision date
Received
(31 days to decision)
Product code
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Regulation
21 CFR 870.1220
Device class
Class II
Review panel
Cardiovascular
Applicant
Rhythmia Medical, Inc. 111 S. Bedford St. Suite 205, Burlington MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRF

Trailing 12 months
1 clearance under product code DRF in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260