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FDA 510(k)

PCA Syringe Sets

K-Number: K212262 · 2022-10-03

ApplicantBaxter Healthcare Corporation
Decision Date2022-10-03
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PCA Syringe Sets 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 2022-10-03 under 510(k) number K212262. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PCA Syringe Sets?

PCA Syringe Sets is a medical device that received FDA 510(k) clearance on 2022-10-03. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K212262.

When did PCA Syringe Sets receive FDA 510(k) clearance?

PCA Syringe Sets received FDA 510(k) clearance on 2022-10-03, under 510(k) number K212262.

Who is the listed applicant for PCA Syringe Sets?

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 PCA Syringe Sets?

The FDA product code for PCA Syringe Sets is FPA.

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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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