510(k) K211649
- Device
- PCEA Syringe Set
- Applicant
- Baxter Healthcare Corporation
- 510(k) number
- K211649
- Product code
- PWH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-11-23
- Date received
- 2021-05-28
- Regulation
- 880.5440
- Classification name
- Administrations Sets With Neuraxial Connectors
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Jeffrey E Thompson
- Address
- 25212 W. Illinois Rte. 120 Round Lake IL US 60073 60073
FDA Registration Numbers
- 2032112
- 9612052
- 9617604
- 3005941719
- 3012307300
- 1416980
- 1526863
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code PWH
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221319 | BD Alaris Pump Epidural Infusion Set | Care Fusion | 2023-07-21 |
| K172592 | CADD Yellow High Volume Administration Set with NRFit connector | Smiths Medical Asd, Inc. | 2018-05-17 |
| K162219 | CADD® Infusion Disposables Portfolio with NRFit connectors | Smiths Medical Asd, Inc. | 2017-07-20 |