FDA 510(k)

Surefire Spark Infusion System

Número K: K180677 · 2018-04-03

Data da decisão2018-04-03

Código do produtoDQO

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Surefire Spark Infusion System is the device name listed in this FDA 510(k) record. The listed applicant is Surefire Medical, Inc.. It received FDA 510(k) clearance on 2018-04-03 under 510(k) number K180677. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Surefire Medical, Inc.. The 510(k) number is K180677.

When did Surefire Spark Infusion System receive FDA 510(k) clearance?

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

Who is the listed applicant for Surefire Spark Infusion System?

The FDA 510(k) record lists Surefire Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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Outros registros que listam Surefire Medical, Inc. como candidato(a)

K171355Surefire Precision Infusion System K162359Surefire Guiding Catheter K160662Surefire Infusion System

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Fonte oficial

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