coraForce and coraFlex Support Catheters
K-Number: K201811 · 2020-10-26
ApplicantReflow Medical, Inc.
Decision Date2020-10-26
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
coraForce and coraFlex Support Catheters is a medical device manufactured by Reflow Medical, Inc.. It received FDA 510(k) clearance on 2020-10-26 under approval number K201811. 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 coraForce and coraFlex Support Catheters?
coraForce and coraFlex Support Catheters is a medical device that received FDA 510(k) clearance on 2020-10-26. It is manufactured by Reflow Medical, Inc.. The 510(k) number is K201811.
When was coraForce and coraFlex Support Catheters approved by the FDA?
coraForce and coraFlex Support Catheters received FDA 510(k) clearance on 2020-10-26, under approval number K201811.
What company makes coraForce and coraFlex Support Catheters?
coraForce and coraFlex Support Catheters is manufactured by Reflow Medical, Inc..
What is the FDA product code for coraForce and coraFlex Support Catheters?
The FDA product code for coraForce and coraFlex Support Catheters is DQY.
Related Clinical Trials
Other Devices by Reflow Medical, Inc.
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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.