Cleared Special

Agilis NxT Steerable Introducer Dual-Reach

K243493 · Abbott Medical · Cardiovascular
Dec 2024
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K243493 is an FDA 510(k) clearance for the Agilis NxT Steerable Introducer Dual-Reach, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Abbott Medical (Minnetonka, US). The FDA issued a Cleared decision on December 13, 2024, 31 days after receiving the submission on November 12, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K243493 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2024
Decision Date December 13, 2024
Days to Decision 31 days
Submission Type Special
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