Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer
FDA 510(k) clearance K250314 · decided 2025-12-19
Clearance details
- K-number
- K250314
- Device name
- Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer
- Applicant
- Surgical Instrument Service and Savings, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-02-04
- Decision date
- 2025-12-19
- Days to decision
- 318 days
- Clearance type
- Traditional
- Product code
- PNE
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Redmond, OR, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Reprocessed Agilis NxT Steerable Introducer (K250305) | Innovative Health | 2026-01-07 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.