PNE
7 FDA 510(k) clearances · Product code
241 daysmedian time to decision
338 days90th percentile
7clearances measured
FDA profile
- Official device name
- Reprocessed Catheter Introducer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Medical specialty
- Cardiovascular
- FDA definition
- Introduce various cardiovascular catheters into the heart and cardiovascular system
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Reprocessed Agilis NxT Steerable Introducer (K250305) | Innovative Health | 2026-01-07 |
| Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer (K250314) | Surgical Instrument Service and Savings, Inc. | 2025-12-19 |
| Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath (K232037) | Innovative Health, LLC | 2024-04-04 |
| Reprocessed Agilis NxT Steerable Introducer (K230376) | Innovative Health, LLC | 2023-08-07 |
| Reprocessed Carto Vizigo Bi-Directional Guiding Sheath (K212165) | Innovative Health, LLC | 2022-03-10 |
| Reprocessed Agilis NxT Steerable Introducer (K170311) | Innovative Health, LLC | 2017-06-02 |
| Reprocessed Steerable Introducer (K152090) | Sterilmed, Inc. | 2016-03-23 |
Track PNE automatically
Every clearance here is in the API, with alerts when new ones post.