Cleared Traditional

Talon Transseptal Sheath

K231108 · Inari Medical, Inc. · Cardiovascular
Sep 2023
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K231108 is an FDA 510(k) clearance for the Talon Transseptal Sheath, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Inari Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on September 27, 2023, 161 days after receiving the submission on April 19, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K231108 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2023
Decision Date September 27, 2023
Days to Decision 161 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