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FDA 510(k)

Aprima Smartesis Centesis Pump

K-Number: K161002 · 2016-09-28

ApplicantCook Incorporated
Decision Date2016-09-28
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Aprima Smartesis Centesis Pump is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2016-09-28 under 510(k) 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. The listed applicant is Cook Incorporated. The 510(k) number is K161002.

When did Aprima Smartesis Centesis Pump receive FDA 510(k) clearance?

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

Who is the listed applicant for Aprima Smartesis Centesis Pump?

The FDA 510(k) record lists Cook Incorporated as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: BTA)

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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