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FDA 510(k)

Intravascular Administration Sets

K-Number: K203609 · 2021-09-30

ApplicantBaxter Healthcare Corporation
Decision Date2021-09-30
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Intravascular Administration 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 2021-09-30 under 510(k) number K203609. 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 Intravascular Administration Sets?

Intravascular Administration Sets is a medical device that received FDA 510(k) clearance on 2021-09-30. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K203609.

When did Intravascular Administration Sets receive FDA 510(k) clearance?

Intravascular Administration Sets received FDA 510(k) clearance on 2021-09-30, under 510(k) number K203609.

Who is the listed applicant for Intravascular Administration 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 Intravascular Administration Sets?

The FDA product code for Intravascular Administration 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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