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FDA 510(k)

Surefire Spark Infusion System

K-Number: K180677 · 2018-04-03

ApplicantSurefire Medical, Inc.
Decision Date2018-04-03
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Surefire Spark Infusion System is a medical device manufactured by Surefire Medical, Inc.. It received FDA 510(k) clearance on 2018-04-03 under approval number K180677. 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 Spark Infusion System?

Surefire Spark Infusion System is a medical device that received FDA 510(k) clearance on 2018-04-03. It is manufactured by Surefire Medical, Inc.. The 510(k) number is K180677.

When was Surefire Spark Infusion System approved by the FDA?

Surefire Spark Infusion System received FDA 510(k) clearance on 2018-04-03, under approval number K180677.

What company makes Surefire Spark Infusion System?

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

What is the FDA product code for Surefire Spark Infusion System?

The FDA product code for Surefire Spark Infusion System is DQO.

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Other Devices by Surefire Medical, Inc.

K162359Surefire Guiding Catheter K160662Surefire Infusion System K171355Surefire Precision Infusion System

Related Devices (Code: DQO)

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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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