Cleared Traditional

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

K230631 · Argon Medical Devices · Cardiovascular device

May 2023

Decision

76d

Days

Class 2

Risk

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

Submitted by Argon Medical Devices (Athens, US). The FDA issued a Cleared decision on May 22, 2023, 76 days after receiving the submission on March 7, 2023.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.

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