Wingman 18 Crossing Catheter
K-Number: K160848 · 2016-07-14
ApplicantReflow Medical, Inc.
Decision Date2016-07-14
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Wingman 18 Crossing Catheter is a medical device manufactured by Reflow Medical, Inc.. It received FDA 510(k) clearance on 2016-07-14 under approval number K160848. 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 18 Crossing Catheter?
Wingman 18 Crossing Catheter is a medical device that received FDA 510(k) clearance on 2016-07-14. It is manufactured by Reflow Medical, Inc.. The 510(k) number is K160848.
When was Wingman 18 Crossing Catheter approved by the FDA?
Wingman 18 Crossing Catheter received FDA 510(k) clearance on 2016-07-14, under approval number K160848.
What company makes Wingman 18 Crossing Catheter?
Wingman 18 Crossing Catheter is manufactured by Reflow Medical, Inc..
What is the FDA product code for Wingman 18 Crossing Catheter?
The FDA product code for Wingman 18 Crossing Catheter 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.