Cleared Traditional

RithmID-SD Steerable Diagnostic Electrophysiology Catheter

K203793 · Synaptic Medical Corporation · Cardiovascular

Feb 2022

Decision

413d

Days

Class 2

Risk

About This 510(k) Submission

K203793 is an FDA 510(k) clearance for the RithmID-SD Steerable Diagnostic Electrophysiology Catheter, a Catheter, Electrode Recording, Or Probe, Electrode Recording (Class II — Special Controls, product code DRF), submitted by Synaptic Medical Corporation (Carlsbad, US). The FDA issued a Cleared decision on February 14, 2022, 413 days after receiving the submission on December 28, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number	K203793 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 28, 2020
Decision Date	February 14, 2022
Days to Decision	413 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