Cleared Traditional

Reprocessed Agilis NxT Steerable Introducer

K250305 · Innovative Health · Cardiovascular

Jan 2026

Decision

338d

Days

Class 2

Risk

About This 510(k) Submission

K250305 is an FDA 510(k) clearance for the Reprocessed Agilis NxT Steerable Introducer, a Reprocessed Catheter Introducer (Class II — Special Controls, product code PNE), submitted by Innovative Health (Scottsdale, US). The FDA issued a Cleared decision on January 7, 2026, 338 days after receiving the submission on February 3, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number	K250305 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 03, 2025
Decision Date	January 07, 2026
Days to Decision	338 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	PNE — Reprocessed Catheter Introducer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1340
Definition	Introduce Various Cardiovascular Catheters Into The Heart And Cardiovascular System