Cleared Traditional

Accusafe Transseptal Guidewire (GTR31180, GTR31230)

K240246 · Synaptic Medical Corporation · Cardiovascular
Jul 2024
Decision
178d
Days
Class 2
Risk

About This 510(k) Submission

K240246 is an FDA 510(k) clearance for the Accusafe Transseptal Guidewire (GTR31180, GTR31230), a Trocar (Class II — Special Controls, product code DRC), submitted by Synaptic Medical Corporation (Carlsbad, US). The FDA issued a Cleared decision on July 26, 2024, 178 days after receiving the submission on January 30, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1390.

Submission Details

510(k) Number K240246 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 2024
Decision Date July 26, 2024
Days to Decision 178 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRC — Trocar
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1390

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