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FDA 510(k)

coraCross

K-Number: K210188 · 2021-05-28

ApplicantReflow Medical
Decision Date2021-05-28
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

coraCross is a medical device manufactured by Reflow Medical. It received FDA 510(k) clearance on 2021-05-28 under approval number K210188. 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 coraCross?

coraCross is a medical device that received FDA 510(k) clearance on 2021-05-28. It is manufactured by Reflow Medical. The 510(k) number is K210188.

When was coraCross approved by the FDA?

coraCross received FDA 510(k) clearance on 2021-05-28, under approval number K210188.

What company makes coraCross?

coraCross is manufactured by Reflow Medical.

What is the FDA product code for coraCross?

The FDA product code for coraCross is DQY.

Other Devices by Reflow Medical

K200094speX LP Support Catheter K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35 K193012speX Support Catheter

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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.

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