PNE · Reprocessed Catheter Introducer
Cardiovascular · 21 CFR 870.1340 · Class 2
Overview
| Product Code | PNE |
|---|---|
| Device Name | Reprocessed Catheter Introducer |
| Regulation | 21 CFR 870.1340 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
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 | Reprocessed Agilis NxT Steerable Introducer | Innovative Health | Jan 7, 2026 | SESE |
| K250314 | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer | Surgical Instrument Service and Savings, Inc. | Dec 19, 2025 | SESE |
| K232037 | Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath | Innovative Health, LLC | Apr 4, 2024 | SESE |
| K230376 | Reprocessed Agilis NxT Steerable Introducer | Innovative Health, LLC | Aug 7, 2023 | SESE |
| K212165 | Reprocessed Carto Vizigo Bi-Directional Guiding Sheath | Innovative Health, LLC | Mar 10, 2022 | SESE |
| K170311 | Reprocessed Agilis NxT Steerable Introducer | Innovative Health, LLC | Jun 2, 2017 | SESE |
| K152090 | 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
