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FDA 510(k)

PCEA Syringe Set

K-Number: K211649 · 2021-11-23

ApplicantBaxter Healthcare Corporation
Decision Date2021-11-23
Product CodePWH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PCEA Syringe Set is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2021-11-23 under 510(k) 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. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K211649.

When did PCEA Syringe Set receive FDA 510(k) clearance?

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

Who is the listed applicant for PCEA Syringe Set?

The FDA 510(k) record lists Baxter Healthcare Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

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