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FDA 510(k)

Prismaflex System 8.10

K-Number: K171671 · 2018-02-23

ApplicantBaxter Healthcare Corporation
Decision Date2018-02-23
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Prismaflex System 8.10 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 2018-02-23 under 510(k) number K171671. 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 System 8.10?

Prismaflex System 8.10 is a medical device that received FDA 510(k) clearance on 2018-02-23. The listed applicant is Baxter Healthcare Corporation. The 510(k) number is K171671.

When did Prismaflex System 8.10 receive FDA 510(k) clearance?

Prismaflex System 8.10 received FDA 510(k) clearance on 2018-02-23, under 510(k) number K171671.

Who is the listed applicant for Prismaflex System 8.10?

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 System 8.10?

The FDA product code for Prismaflex System 8.10 is KDI.

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Related Devices (Code: KDI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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