Cleared Traditional

Reprocessed Agilis NxT Steerable Introducer

K170311 · Innovative Health, LLC · Cardiovascular

Jun 2017

Decision

121d

Days

Class 2

Risk

About This 510(k) Submission

K170311 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 June 2, 2017, 121 days after receiving the submission on February 1, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number	K170311 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 2017
Decision Date	June 02, 2017
Days to Decision	121 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