Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1340](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1340) → PNE — Reprocessed Catheter Introducer

# PNE · Reprocessed Catheter Introducer

_Cardiovascular · 21 CFR 870.1340 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNE

## Overview

- **Product Code:** PNE
- **Device Name:** Reprocessed Catheter Introducer
- **Regulation:** [21 CFR 870.1340](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1340)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K250305](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNE/K250305.md) | Reprocessed Agilis NxT Steerable Introducer | Innovative Health | Jan 7, 2026 | SESE |
| [K250314](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNE/K250314.md) | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer | Surgical Instrument Service and Savings, Inc. | Dec 19, 2025 | SESE |
| [K232037](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNE/K232037.md) | Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath | Innovative Health, LLC | Apr 4, 2024 | SESE |
| [K230376](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNE/K230376.md) | Reprocessed Agilis NxT Steerable Introducer | Innovative Health, LLC | Aug 7, 2023 | SESE |
| [K212165](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNE/K212165.md) | Reprocessed Carto Vizigo Bi-Directional Guiding Sheath | Innovative Health, LLC | Mar 10, 2022 | SESE |
| [K170311](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNE/K170311.md) | Reprocessed Agilis NxT Steerable Introducer | Innovative Health, LLC | Jun 2, 2017 | SESE |
| [K152090](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNE/K152090.md) | Reprocessed Steerable Introducer | Sterilmed, Inc. | Mar 23, 2016 | SESE |

## Top Applicants

- Innovative Health, LLC — 4 clearances
- Innovative Health — 1 clearance
- Sterilmed, Inc. — 1 clearance
- Surgical Instrument Service and Savings, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNE](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PNE)

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