510(k) K232037
- Device
- Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath
- Applicant
- Innovative Health, LLC
- 510(k) number
- K232037
- Product code
- PNE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-04-04
- Date received
- 2023-07-10
- 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
- No
Related Records
Applicant Contact
- Contact
- Rick Ferreira
- Address
- 1435 N. Hayden Rd. Suite 100 Scottsdale AZ US 85257 85257
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 |
| K250314 | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer | Surgical Instrument Service and Savings, Inc. | 2025-12-19 |
| 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 |