Wingman 14C Crossing Catheter
K-Number: K190393 · 2019-05-09
ApplicantReflow Medical, Inc.
Decision Date2019-05-09
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Wingman 14C Crossing Catheter is a medical device manufactured by Reflow Medical, Inc.. It received FDA 510(k) clearance on 2019-05-09 under approval number K190393. 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 14C Crossing Catheter?
Wingman 14C Crossing Catheter is a medical device that received FDA 510(k) clearance on 2019-05-09. It is manufactured by Reflow Medical, Inc.. The 510(k) number is K190393.
When was Wingman 14C Crossing Catheter approved by the FDA?
Wingman 14C Crossing Catheter received FDA 510(k) clearance on 2019-05-09, under approval number K190393.
What company makes Wingman 14C Crossing Catheter?
Wingman 14C Crossing Catheter is manufactured by Reflow Medical, Inc..
What is the FDA product code for Wingman 14C Crossing Catheter?
The FDA product code for Wingman 14C 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.