Cleared Traditional

K231108 - Talon Transseptal Sheath

K231108 is an FDA 510(k) clearance for Talon Transseptal Sheath, manufactured by Inari Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K231108 · Inari Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
161d
Days
Class 2
Risk

K231108 is an FDA 510(k) clearance for the Talon Transseptal Sheath. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Inari Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on September 27, 2023 after a review of 161 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Inari Medical, Inc. devices

FDA 510(k) Submission Details - K231108

510(k) Number K231108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 125d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DYB Introducer, Catheter

All 595
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K231108.
Intri24 Introducer Sheath (52-101)
K233646 · Inari Medical, Inc. · Dec 2023
10F Sheath and Dilator Set
K233432 · Argon Medical Devices, Inc. · Dec 2023
14F iSLEEVE Introducer Set
K233503 · Boston Scientific Corporation · Nov 2023
Thinline Sheath Introducer
K232260 · Inneuroco, Inc. · Sep 2023
Pounce™ Sheath
K231828 · Surmodics,Inc. · Sep 2023
CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)
K231412 · Biosense Webster, Inc. · Jul 2023