Cleared Traditional

Extra Large Check-Flo Introducer

K203670 · Cook Incorporated · Cardiovascular
Feb 2021
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K203670 is an FDA 510(k) clearance for the Extra Large Check-Flo Introducer, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on February 16, 2021, 62 days after receiving the submission on December 16, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K203670 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2020
Decision Date February 16, 2021
Days to Decision 62 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