FDA 510(k)

Surefire Infusion System

K-Number: K160662 · 2016-03-11

Decision Date2016-03-11

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Surefire Infusion System is a medical device manufactured by Surefire Medical, Inc.. It received FDA 510(k) clearance on 2016-03-11 under approval number K160662. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surefire Infusion System?

Surefire Infusion System is a medical device that received FDA 510(k) clearance on 2016-03-11. It is manufactured by Surefire Medical, Inc.. The 510(k) number is K160662.

When was Surefire Infusion System approved by the FDA?

Surefire Infusion System received FDA 510(k) clearance on 2016-03-11, under approval number K160662.

What company makes Surefire Infusion System?

Surefire Infusion System is manufactured by Surefire Medical, Inc..

What is the FDA product code for Surefire Infusion System?

The FDA product code for Surefire Infusion System is DQO.

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Other Devices by Surefire Medical, Inc.

K162359Surefire Guiding Catheter K171355Surefire Precision Infusion System K180677Surefire Spark Infusion System

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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.