FDA 510(k)

PrisMax Control Unit

K-Number: K163530 · 2017-05-03

Decision Date2017-05-03

Product CodeKDI

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

PrisMax Control Unit is a medical device manufactured by Baxter Healthcare Corp. It received FDA 510(k) clearance on 2017-05-03 under approval number K163530. 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 Control Unit?

PrisMax Control Unit is a medical device that received FDA 510(k) clearance on 2017-05-03. It is manufactured by Baxter Healthcare Corp. The 510(k) number is K163530.

When was PrisMax Control Unit approved by the FDA?

PrisMax Control Unit received FDA 510(k) clearance on 2017-05-03, under approval number K163530.

What company makes PrisMax Control Unit?

PrisMax Control Unit is manufactured by Baxter Healthcare Corp.

What is the FDA product code for PrisMax Control Unit?

The FDA product code for PrisMax Control Unit is KDI.

Other Devices by Baxter Healthcare Corp

K190910PrisMax System Version 2 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.