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FDA 510(k)

Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set

K-Number: K212216 · 2022-04-01

ApplicantBaxter Healthcare Corporation
Decision Date2022-04-01
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 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 2022-04-01 under 510(k) number K212216. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set?

Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set is a medical device that received FDA 510(k) clearance on 2022-04-01. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K212216.

When did Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set receive FDA 510(k) clearance?

Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set received FDA 510(k) clearance on 2022-04-01, under 510(k) number K212216.

Who is the listed applicant for Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 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 Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set?

The FDA product code for Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set is KDI.

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Related Devices (Code: KDI)

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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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