Cleared Special

Intri24 Introducer Sheath (52-101)

K233646 · Inari Medical, Inc. · Cardiovascular
Dec 2023
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K233646 is an FDA 510(k) clearance for the Intri24 Introducer Sheath (52-101), a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Inari Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on December 12, 2023, 28 days after receiving the submission on November 14, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K233646 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 2023
Decision Date December 12, 2023
Days to Decision 28 days
Submission Type Special
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