Panels › Cardiovascular › Product code PNE · Class 2
Reprocessed Catheter Introducer
Regulation 870.1340
2510(k)s in 12 months (7 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PNE
| Company | 510(k)s | Recalls |
|---|---|---|
| Innovative Health | 5 | 0 |
| Sterilmed, Inc. | 1 | 0 |
| Surgical Instrument Service and Savings, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 7, 2026 | K250305 | Reprocessed Agilis NxT Steerable Introducer Innovative Health | PNE |
| Dec 19, 2025 | K250314 | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer Surgical Instrument Service and Savings, Inc. | PNE |
| Apr 4, 2024 | K232037 | Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath Innovative Health, LLC | PNE |
| Aug 7, 2023 | K230376 | Reprocessed Agilis NxT Steerable Introducer Innovative Health, LLC | PNE |
| Mar 10, 2022 | K212165 | Reprocessed Carto Vizigo Bi-Directional Guiding Sheath Innovative Health, LLC | PNE |
| Jun 2, 2017 | K170311 | Reprocessed Agilis NxT Steerable Introducer Innovative Health, LLC | PNE |
| Mar 23, 2016 | K152090 | Reprocessed Steerable Introducer Sterilmed, Inc. | PNE |
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