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FDA 510(k)

Intravascular Extension Set

K-Number: K210430 · 2021-06-18

ApplicantBaxter Healthcare Corporation
Decision Date2021-06-18
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Intravascular Extension 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 2021-06-18 under 510(k) number K210430. 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 Set?

Intravascular Extension Set is a medical device that received FDA 510(k) clearance on 2021-06-18. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K210430.

When did Intravascular Extension Set receive FDA 510(k) clearance?

Intravascular Extension Set received FDA 510(k) clearance on 2021-06-18, under 510(k) number K210430.

Who is the listed applicant for Intravascular Extension 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 Intravascular Extension Set?

The FDA product code for Intravascular Extension Set 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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