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FDA 510(k)

Intravascular Extension Sets and Accessories

K-Number: K242339 · 2025-02-28

ApplicantBaxter Healthcare Corporation
Decision Date2025-02-28
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Intravascular Extension Sets and Accessories 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 2025-02-28 under 510(k) number K242339. 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 Extension Sets and Accessories?

Intravascular Extension Sets and Accessories is a medical device that received FDA 510(k) clearance on 2025-02-28. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K242339.

When did Intravascular Extension Sets and Accessories receive FDA 510(k) clearance?

Intravascular Extension Sets and Accessories received FDA 510(k) clearance on 2025-02-28, under 510(k) number K242339.

Who is the listed applicant for Intravascular Extension Sets and Accessories?

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 Extension Sets and Accessories?

The FDA product code for Intravascular Extension Sets and Accessories 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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