Cleared Traditional

Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter

K183547 · Medtronic · Cardiovascular

Jul 2019

Decision

222d

Days

Class 2

Risk

About This 510(k) Submission

K183547 is an FDA 510(k) clearance for the Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter, a Catheter, Electrode Recording, Or Probe, Electrode Recording (Class II — Special Controls, product code DRF), submitted by Medtronic (Mounds View, US). The FDA issued a Cleared decision on July 30, 2019, 222 days after receiving the submission on December 20, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number	K183547 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 2018
Decision Date	July 30, 2019
Days to Decision	222 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DRF — Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1220