Reprocessed Agilis NxT Steerable Introducer— 510(k) K250305

Name: FDA 510(k) clearance K250305
Creator: U.S. Food and Drug Administration
Published: 2026-01-07

Substantially Equivalent

Innovative Health

FDA 510(k) clearance K250305 for Reprocessed Agilis NxT Steerable Introducer, Substantially Equivalent on 2026-01-07. Applicant: Innovative Health. Device class: 2.

Clearance details

Applicant: Innovative Health
Product code: Code PNE
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2025-02-03
Decision date: 2026-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PNE

view all

K250314 — Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer2025-12-19
K232037 — Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath2024-04-04
K230376 — Reprocessed Agilis NxT Steerable Introducer2023-08-07
K212165 — Reprocessed Carto Vizigo Bi-Directional Guiding Sheath2022-03-10
K170311 — Reprocessed Agilis NxT Steerable Introducer2017-06-02

More clearances from Innovative Health

view all

K233825 — Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter2024-06-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.