Cleared Traditional

FlexCath Cross Transseptal Solution

K233691 · Acutus Medical, Inc. · Cardiovascular
Dec 2023
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K233691 is an FDA 510(k) clearance for the FlexCath Cross Transseptal Solution, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Acutus Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on December 17, 2023, 31 days after receiving the submission on November 16, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K233691 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 2023
Decision Date December 17, 2023
Days to Decision 31 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