Cleared Traditional

Intri26 Introducer Sheath

K252508 · Inari Medical, Inc. · Cardiovascular
Dec 2025
Decision
131d
Days
Class 2
Risk

About This 510(k) Submission

K252508 is an FDA 510(k) clearance for the Intri26 Introducer 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 December 17, 2025, 131 days after receiving the submission on August 8, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K252508 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 2025
Decision Date December 17, 2025
Days to Decision 131 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

Similar Devices — DYB Introducer, Catheter

All 692
AuST CSP Introducer
K260163 · CenterPoint Systems, LLC · Feb 2026
Peel-Away Introducer Sheath
K254236 · VascuTech Medical, LLC · Feb 2026
Genie MAX Large Bore Introducer Sheath
K253652 · Cultiv8 1, LLC · Jan 2026
V?Stick? Vascular Access Set
K253741 · Argon Medical Devices, Inc. · Dec 2025
PerQseal Introducers
K252309 · Vivasure Medical Limited · Oct 2025
Introducer Sheath Set
K251838 · Cardiocycle Medical(Suzhou) Co., Ltd. · Oct 2025