Cleared Traditional

Thinline Sheath Introducer (K232260) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232260 · Inneuroco, Inc. · Cardiovascular device
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Sep 2023
Decision
58d
Days
Class 2
Risk

K232260 is an FDA 510(k) clearance for the Thinline Sheath Introducer. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Inneuroco, Inc. (Pembroke Pines, US). The FDA issued a Cleared decision on September 27, 2023 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Inneuroco, Inc. devices

Submission Details

510(k) Number K232260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2023
Decision Date September 27, 2023
Days to Decision 58 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 125d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 278
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K232260.
10F Sheath and Dilator Set
K233432 · Argon Medical Devices, Inc. · Dec 2023
14F iSLEEVE Introducer Set
K233503 · Boston Scientific Corporation · Nov 2023
Talon Transseptal Sheath
K231108 · Inari Medical, 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
Kodiak™ Dual Port Coaxial Introducer Kit
K230631 · Argon Medical Devices · May 2023