Cleared Traditional

Intri24 Sheath

K212392 · Inari Medical, Inc. · Cardiovascular
Apr 2022
Decision
242d
Days
Class 2
Risk

About This 510(k) Submission

K212392 is an FDA 510(k) clearance for the Intri24 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 April 1, 2022, 242 days after receiving the submission on August 2, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K212392 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2021
Decision Date April 01, 2022
Days to Decision 242 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