Cleared Special

Agilis? NxT Steerable Introducer Dual-Reach? (I-V2-MED)

K241370 · Abbott Medical · Cardiovascular
Jun 2024
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K241370 is an FDA 510(k) clearance for the Agilis? NxT Steerable Introducer Dual-Reach? (I-V2-MED), a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Abbott Medical (Minnetonka, US). The FDA issued a Cleared decision on June 13, 2024, 30 days after receiving the submission on May 14, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K241370 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 2024
Decision Date June 13, 2024
Days to Decision 30 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