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FDA 510(k)

speX Support Catheter

K-Number: K173662 · 2017-12-20

ApplicantReflow Medical, Inc.
Decision Date2017-12-20
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

speX Support Catheter is a medical device manufactured by Reflow Medical, Inc.. It received FDA 510(k) clearance on 2017-12-20 under approval number K173662. 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 2017-12-20. It is manufactured by Reflow Medical, Inc.. The 510(k) number is K173662.

When was speX Support Catheter approved by the FDA?

speX Support Catheter received FDA 510(k) clearance on 2017-12-20, under approval number K173662.

What company makes speX Support Catheter?

speX Support Catheter is manufactured by Reflow Medical, Inc..

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, Inc.

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Related Devices (Code: 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.

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