Reprocessed Agilis NxT Steerable Introducer
FDA 510(k) K230376 · Innovative Health, LLC
510(k) numberK230376
Submission
- Device name
- Reprocessed Agilis NxT Steerable Introducer
- Applicant
- Innovative Health, LLC
Scottsdale, AZ, US - Received
- February 13, 2023
- Decision date
- August 7, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PNE – Reprocessed Catheter Introducer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
Introduce various cardiovascular catheters into the heart and cardiovascular system
Other 510(k)s with product code PNE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250305 | Reprocessed Agilis NxT Steerable IntroducerPNE · Traditional | Innovative Health | 01/07/2026SE |
| K250314 | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerPNE · Traditional | Surgical Instrument Service and Savings, Inc. | 12/19/2025SE |
| K232037 | Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding SheathPNE · Traditional | Innovative Health, LLC | 04/04/2024SE |
| K212165 | Reprocessed Carto Vizigo Bi-Directional Guiding SheathPNE · Traditional | Innovative Health, LLC | 03/10/2022SE |
| K170311 | Reprocessed Agilis NxT Steerable IntroducerPNE · Traditional | Innovative Health, LLC | 06/02/2017SE |
| K152090 | Reprocessed Steerable IntroducerPNE · Traditional | Sterilmed, Inc. | 03/23/2016SE |
More from Sterilmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250305 | Reprocessed Agilis NxT Steerable IntroducerPNE · Traditional | 01/07/2026SE |
| K231015 | Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic CathetersNLI · Traditional | 07/01/2024SE |
| K233825 | Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterNLH · Traditional | 06/07/2024SE |
| K232037 | Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding SheathPNE · Traditional | 04/04/2024SE |
| K213584 | Reprocessed NRG Transseptal NeedleQLZ · Traditional | 04/04/2023SE |
| K221854 | Reprocesses Umbilical CableNLH · Traditional | 08/06/2022SE |
| K210655 | Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterOWQ · Traditional | 05/25/2022SE |
| K212165 | Reprocessed Carto Vizigo Bi-Directional Guiding SheathPNE · Traditional | 03/10/2022SE |
| K212776 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledNLG · Traditional | 12/20/2021SE |
| K211662 | Reprocessed IntellaMap Orion High Resolution Mapping CatheterNLG · Traditional | 11/18/2021SE |
Questions and answers
When was Reprocessed Agilis NxT Steerable Introducer cleared by the FDA?
Reprocessed Agilis NxT Steerable Introducer (K230376) received a 510(k) decision of Substantially Equivalent on August 7, 2023, 175 days after the submission was received.
What is the product code of K230376?
The FDA product code is PNE – Reprocessed Catheter Introducer, a Class II (moderate risk) device regulated under 21 CFR 870.1340.