Wingman 14, Wingman 14C, Wingman 18, Wingman 35
K-Number: K193596 · 2020-02-20
ApplicantReflow Medical
Decision Date2020-02-20
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Wingman 14, Wingman 14C, Wingman 18, Wingman 35 is a medical device manufactured by Reflow Medical. It received FDA 510(k) clearance on 2020-02-20 under approval number K193596. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Wingman 14, Wingman 14C, Wingman 18, Wingman 35?
Wingman 14, Wingman 14C, Wingman 18, Wingman 35 is a medical device that received FDA 510(k) clearance on 2020-02-20. It is manufactured by Reflow Medical. The 510(k) number is K193596.
When was Wingman 14, Wingman 14C, Wingman 18, Wingman 35 approved by the FDA?
Wingman 14, Wingman 14C, Wingman 18, Wingman 35 received FDA 510(k) clearance on 2020-02-20, under approval number K193596.
What company makes Wingman 14, Wingman 14C, Wingman 18, Wingman 35?
Wingman 14, Wingman 14C, Wingman 18, Wingman 35 is manufactured by Reflow Medical.
What is the FDA product code for Wingman 14, Wingman 14C, Wingman 18, Wingman 35?
The FDA product code for Wingman 14, Wingman 14C, Wingman 18, Wingman 35 is DQY.
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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.