FDA 510(k)

PCEA Syringe Set

K-Number: K211649 · 2021-11-23

Decision Date2021-11-23

Product CodePWH

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PCEA Syringe Set is a medical device manufactured by Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2021-11-23 under approval number K211649. The device is classified under product code PWH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PCEA Syringe Set?

PCEA Syringe Set is a medical device that received FDA 510(k) clearance on 2021-11-23. It is manufactured by Baxter Healthcare Corporation. The 510(k) number is K211649.

When was PCEA Syringe Set approved by the FDA?

PCEA Syringe Set received FDA 510(k) clearance on 2021-11-23, under approval number K211649.

What company makes PCEA Syringe Set?

PCEA Syringe Set is manufactured by Baxter Healthcare Corporation.

What is the FDA product code for PCEA Syringe Set?

The FDA product code for PCEA Syringe Set is PWH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.