510(k) K250314
- Device
- Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer
- Applicant
- Surgical Instrument Service and Savings, Inc.
- 510(k) number
- K250314
- Product code
- PNE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-12-19
- Date received
- 2025-02-04
- Regulation
- 870.1340
- Classification name
- Reprocessed Catheter Introducer
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Stephanie Boyle Mays
- Address
- (Dba Medline Renewal) 1500 NE Hemlock Ave. Redmond OR US 97756 97756
FDA Registration Numbers
- 3011024991
- 2032112
- 3032391
- 3011610434
Source Documents
Other 510(k) Records For Product Code PNE
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250305 | Reprocessed Agilis NxT Steerable Introducer | Innovative Health | 2026-01-07 |
| K232037 | Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath | Innovative Health, LLC | 2024-04-04 |
| K230376 | Reprocessed Agilis NxT Steerable Introducer | Innovative Health, LLC | 2023-08-07 |
| K212165 | Reprocessed Carto Vizigo Bi-Directional Guiding Sheath | Innovative Health, LLC | 2022-03-10 |
| K170311 | Reprocessed Agilis NxT Steerable Introducer | Innovative Health, LLC | 2017-06-02 |
| K152090 | Reprocessed Steerable Introducer | Sterilmed, Inc. | 2016-03-23 |