CADD Yellow High Volume Administration Set with NRFit connector
FDA 510(k) K172592 · Smiths Medical Asd, Inc.
510(k) numberK172592
Submission
- Device name
- CADD Yellow High Volume Administration Set with NRFit connector
- Applicant
- Smiths Medical Asd, Inc.
Plymouth, MN, US - Received
- August 29, 2017
- Decision date
- May 17, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PWH – Administrations Sets With Neuraxial Connectors
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.
Other 510(k)s with product code PWH
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|---|---|---|---|
| K221319 | BD Alaris Pump Epidural Infusion SetPWH · Traditional | Care Fusion | 07/21/2023SE |
| K211649 | PCEA Syringe SetPWH · Traditional | Baxter Healthcare Corporation | 11/23/2021SE |
| K162219 | CADD® Infusion Disposables Portfolio with NRFit connectorsPWH · Traditional | Smiths Medical Asd, Inc. | 07/20/2017SE |
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Questions and answers
When was CADD Yellow High Volume Administration Set with NRFit connector cleared by the FDA?
CADD Yellow High Volume Administration Set with NRFit connector (K172592) received a 510(k) decision of Substantially Equivalent on May 17, 2018, 261 days after the submission was received.
What is the product code of K172592?
The FDA product code is PWH – Administrations Sets With Neuraxial Connectors, a Class II (moderate risk) device regulated under 21 CFR 880.5440.