FDA 510(k)

Aprima Smartesis Centesis Pump

K-Number: K161002 · 2016-09-28

Decision Date2016-09-28

Product CodeBTA

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Aprima Smartesis Centesis Pump is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2016-09-28 under approval number K161002. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aprima Smartesis Centesis Pump?

Aprima Smartesis Centesis Pump is a medical device that received FDA 510(k) clearance on 2016-09-28. It is manufactured by Cook Incorporated. The 510(k) number is K161002.

When was Aprima Smartesis Centesis Pump approved by the FDA?

Aprima Smartesis Centesis Pump received FDA 510(k) clearance on 2016-09-28, under approval number K161002.

What company makes Aprima Smartesis Centesis Pump?

Aprima Smartesis Centesis Pump is manufactured by Cook Incorporated.

What is the FDA product code for Aprima Smartesis Centesis Pump?

The FDA product code for Aprima Smartesis Centesis Pump is BTA.

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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.