FDA 510(k)

speX Support Catheter

K-Number: K193012 · 2020-02-19

Decision Date2020-02-19

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

speX Support Catheter is a medical device manufactured by Reflow Medical. It received FDA 510(k) clearance on 2020-02-19 under approval number K193012. 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 speX Support Catheter?

speX Support Catheter is a medical device that received FDA 510(k) clearance on 2020-02-19. It is manufactured by Reflow Medical. The 510(k) number is K193012.

When was speX Support Catheter approved by the FDA?

speX Support Catheter received FDA 510(k) clearance on 2020-02-19, under approval number K193012.

What company makes speX Support Catheter?

speX Support Catheter is manufactured by Reflow Medical.

What is the FDA product code for speX Support Catheter?

The FDA product code for speX Support Catheter is DQY.

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Other Devices by Reflow Medical

K200094speX LP Support Catheter K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35 K210188coraCross

Related Devices (Code: DQY)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.