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Reprocessed Agilis NxT Steerable Introducer

by Innovative Health 510(k)

Active United States

510(k) K250305

Overview

The Reprocessed Agilis NxT Steerable Introducer is a reprocessed catheter introducer designed to provide flexible catheter positioning in the cardiac anatomy. It consists of a steerable sheath, dilator, and guidewire, and is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood management.

This device is supplied in a reprocessed state and is intended for use in cardiovascular procedures. It is classified as a Class II medical device under FDA regulation 870.1340 with product code PNE. The device received traditional 510(k) clearance (K250305) and is substantially equivalent to a predicate device. It is not MRI conditional unless explicitly stated, and no sterility, single-use/reusable status, sizes, or storage conditions are specified in the provided data.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK250305 Date7 Jan 2026ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 6 Oct 2026)

Specification

510(k)

510(k) Number
FDA Product Code
PNE
Device Class
Class II
Regulation
21 CFR Part 870.1340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Reprocessed Agilis NxT Steerable Introducer used for?

    It is designed to provide flexible catheter positioning in the cardiac anatomy during cardiovascular procedures, enabling catheter introduction and/or exchange with minimized blood loss via its hemostasis valve.

  • How is the Reprocessed Agilis NxT Steerable Introducer supplied and what components does it include?

    It is supplied in a reprocessed state and consists of a steerable sheath, dilator, guidewire, and a hemostasis valve, with a sideport featuring a three-way stopcock for air or blood management.

  • Is the Reprocessed Agilis NxT Steerable Introducer intended for single-use or reuse?

    The provided data does not specify whether the device is intended for single-use or reuse; no sterility, single-use/reusable status, sizes, or storage conditions are detailed in the device information.