PWH — Administrations Sets With Neuraxial Connectors Class II
Classification Details
- Product Code
- PWH
- Device Class
- Class II
- Regulation Number
- 880.5440
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K221319 | care fusion | BD Alaris Pump Epidural Infusion Set | July 21, 2023 |
| K211649 | baxter healthcare corporation | PCEA Syringe Set | November 23, 2021 |
| K172592 | smiths medical asd | CADD Yellow High Volume Administration Set with NRFit connector | May 17, 2018 |
| K162219 | smiths medical asd | CADD® Infusion Disposables Portfolio with NRFit connectors | July 20, 2017 |