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PNE — Reprocessed Catheter Introducer Class II

FDA Device Classification

Classification Details

Product Code
PNE
Device Class
Class II
Regulation Number
870.1340
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Definition

Introduce various cardiovascular catheters into the heart and cardiovascular system

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250305innovative healthReprocessed Agilis NxT Steerable IntroducerJanuary 7, 2026
K250314surgical instrument service and savingsMedline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerDecember 19, 2025
K232037innovative healthReprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding April 4, 2024
K230376innovative healthReprocessed Agilis NxT Steerable IntroducerAugust 7, 2023
K212165innovative healthReprocessed Carto Vizigo Bi-Directional Guiding SheathMarch 10, 2022
K170311innovative healthReprocessed Agilis NxT Steerable IntroducerJune 2, 2017
K152090sterilmedReprocessed Steerable IntroducerMarch 23, 2016