PCEA Syringe Set
FDA 510(k) K211649 · Baxter Healthcare Corporation
510(k) numberK211649
Submission
- Device name
- PCEA Syringe Set
- Applicant
- Baxter Healthcare Corporation
Round Lake, IL, US - Received
- May 28, 2021
- Decision date
- November 23, 2021
- 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.
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| 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 PCEA Syringe Set cleared by the FDA?
PCEA Syringe Set (K211649) received a 510(k) decision of Substantially Equivalent on November 23, 2021, 179 days after the submission was received.
What is the product code of K211649?
The FDA product code is PWH – Administrations Sets With Neuraxial Connectors, a Class II (moderate risk) device regulated under 21 CFR 880.5440.