FDA Product Code
FDA Product Code PNE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1340
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250305 | Reprocessed Agilis NxT Steerable Introducer | Innovative Health | 2026-01-07 | Traditional | PDF ↗ |
| K250314 | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer | Surgical Instrument Service and Savings, Inc. | 2025-12-19 | Traditional | PDF ↗ |
| K232037 | Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath | Innovative Health, LLC | 2024-04-04 | Traditional | PDF ↗ |
| K230376 | Reprocessed Agilis NxT Steerable Introducer | Innovative Health, LLC | 2023-08-07 | Traditional | PDF ↗ |
| K212165 | Reprocessed Carto Vizigo Bi-Directional Guiding Sheath | Innovative Health, LLC | 2022-03-10 | Traditional | PDF ↗ |
| K170311 | Reprocessed Agilis NxT Steerable Introducer | Innovative Health, LLC | 2017-06-02 | Traditional | PDF ↗ |
| K152090 | Reprocessed Steerable Introducer | Sterilmed, Inc. | 2016-03-23 | Traditional | PDF ↗ |
Product code PNE · Class II · Cardiovascular. Data: openFDA.