Cleared Traditional

Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter

K190132 · Medtronic · Cardiovascular

Jul 2019

Decision

183d

Days

Class 2

Risk

About This 510(k) Submission

K190132 is an FDA 510(k) clearance for the 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, 183 days after receiving the submission on January 28, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number	K190132 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 28, 2019
Decision Date	July 30, 2019
Days to Decision	183 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