Cleared Traditional

Reprocessed Agilis NxT Steerable Introducer

K230376 · Innovative Health, LLC · Cardiovascular

Aug 2023

Decision

175d

Days

Class 2

Risk

About This 510(k) Submission

K230376 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, LLC (Scottsdale, US). The FDA issued a Cleared decision on August 7, 2023, 175 days after receiving the submission on February 13, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number	K230376 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 13, 2023
Decision Date	August 07, 2023
Days to Decision	175 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