Reprocessed Catheter Introducer
FDA product code PNE · Class II (moderate risk) · 21 CFR 870.1340 · Cardiovascular
Introduce various cardiovascular catheters into the heart and cardiovascular system
7510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250305 | Reprocessed Agilis NxT Steerable IntroducerPNE · Traditional | Innovative Health | 01/07/2026SE |
| K250314 | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerPNE · Traditional | Surgical Instrument Service and Savings, Inc. | 12/19/2025SE |
| K232037 | Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding SheathPNE · Traditional | Innovative Health, LLC | 04/04/2024SE |
| K230376 | Reprocessed Agilis NxT Steerable IntroducerPNE · Traditional | Innovative Health, LLC | 08/07/2023SE |
| K212165 | Reprocessed Carto Vizigo Bi-Directional Guiding SheathPNE · Traditional | Innovative Health, LLC | 03/10/2022SE |
| K170311 | Reprocessed Agilis NxT Steerable IntroducerPNE · Traditional | Innovative Health, LLC | 06/02/2017SE |
| K152090 | Reprocessed Steerable IntroducerPNE · Traditional | Sterilmed, Inc. | 03/23/2016SE |