Cleared Traditional

NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01)

K233708 · Synaptic Medical Corporation · Cardiovascular
Feb 2024
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K233708 is an FDA 510(k) clearance for the NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01), a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Synaptic Medical Corporation (Carlsbad, US). The FDA issued a Cleared decision on February 16, 2024, 88 days after receiving the submission on November 20, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K233708 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 2023
Decision Date February 16, 2024
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340