Cleared Traditional

Nordica PV Cryo Mapping Catheter

K233900 · Synaptic Medical Corporation · Cardiovascular

Sep 2024

Decision

270d

Days

Class 2

Risk

About This 510(k) Submission

K233900 is an FDA 510(k) clearance for the Nordica PV Cryo Mapping 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 September 6, 2024, 270 days after receiving the submission on December 11, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number	K233900 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 11, 2023
Decision Date	September 06, 2024
Days to Decision	270 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