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 a medical device manufactured by Baxter Healthcare Corporation. It received FDA 510(k) clearance on 2018-02-23 under approval 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. It is manufactured by Baxter Healthcare Corporation. The 510(k) number is K171671.
When was Prismaflex System 8.10 approved by the FDA?
Prismaflex System 8.10 received FDA 510(k) clearance on 2018-02-23, under approval number K171671.
What company makes Prismaflex System 8.10?
Prismaflex System 8.10 is manufactured by Baxter Healthcare Corporation.
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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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.