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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 a medical device manufactured by Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2022-04-01 under approval 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. It is manufactured by Baxter Healthcare Corporation. The 510(k) number is K212216.

When was Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set approved by the FDA?

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

What company makes Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set?

Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set is manufactured by Baxter Healthcare Corporation.

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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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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