Guidewire 0.6 Single Use
K-Number: K161940 · 2016-09-18
ApplicantFiagon GmbH
Decision Date2016-09-18
Product CodePGW
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Guidewire 0.6 Single Use is a medical device manufactured by Fiagon GmbH. It received FDA 510(k) clearance on 2016-09-18 under approval number K161940. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Guidewire 0.6 Single Use?
Guidewire 0.6 Single Use is a medical device that received FDA 510(k) clearance on 2016-09-18. It is manufactured by Fiagon GmbH. The 510(k) number is K161940.
When was Guidewire 0.6 Single Use approved by the FDA?
Guidewire 0.6 Single Use received FDA 510(k) clearance on 2016-09-18, under approval number K161940.
What company makes Guidewire 0.6 Single Use?
Guidewire 0.6 Single Use is manufactured by Fiagon GmbH.
What is the FDA product code for Guidewire 0.6 Single Use?
The FDA product code for Guidewire 0.6 Single Use is PGW.
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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.