Cleared Traditional

Kodiak™ Dual Port Coaxial Introducer Kit (K230631) - FDA 510(k) Clearance

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

K230631 · Argon Medical Devices · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 2023
Decision
76d
Days
Class 2
Risk

K230631 is an FDA 510(k) clearance for the Kodiak™ Dual Port Coaxial Introducer Kit. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Argon Medical Devices (Athens, US). The FDA issued a Cleared decision on May 22, 2023 after a review of 76 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 Argon Medical Devices devices

Submission Details

510(k) Number K230631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2023
Decision Date May 22, 2023
Days to Decision 76 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
49d faster than avg
Panel avg: 125d · This submission: 76d
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 272
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K230631.
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
RAIN Sheath™ Tibial Pedal Introducer
K230704 · Cordis US Corp · Apr 2023
Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428)
K230283 · Abbott Medical · Mar 2023
Introducer Sheath Kits
K222184 · Beijing Demax Medical Technology Co.,Ltd · Feb 2023