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FDA 510(k)

PrisMax System Version 2

K-Number: K190910 · 2019-07-25

ApplicantBaxter Healthcare Corp
Decision Date2019-07-25
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PrisMax System Version 2 is a medical device manufactured by Baxter Healthcare Corp. It received FDA 510(k) clearance on 2019-07-25 under approval number K190910. 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 PrisMax System Version 2?

PrisMax System Version 2 is a medical device that received FDA 510(k) clearance on 2019-07-25. It is manufactured by Baxter Healthcare Corp. The 510(k) number is K190910.

When was PrisMax System Version 2 approved by the FDA?

PrisMax System Version 2 received FDA 510(k) clearance on 2019-07-25, under approval number K190910.

What company makes PrisMax System Version 2?

PrisMax System Version 2 is manufactured by Baxter Healthcare Corp.

What is the FDA product code for PrisMax System Version 2?

The FDA product code for PrisMax System Version 2 is KDI.

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Other Devices by Baxter Healthcare Corp

K163530PrisMax Control Unit PMA P990009Absorbable collagen hemostatic agent with thrombin PMA P050011Barrier, absorbable, adhesion

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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