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FDA 510(k)

speX LP Support Catheter

K-Number: K200094 · 2020-03-18

ApplicantReflow Medical
Decision Date2020-03-18
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

speX LP Support Catheter is a medical device manufactured by Reflow Medical. It received FDA 510(k) clearance on 2020-03-18 under approval number K200094. 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 LP Support Catheter?

speX LP Support Catheter is a medical device that received FDA 510(k) clearance on 2020-03-18. It is manufactured by Reflow Medical. The 510(k) number is K200094.

When was speX LP Support Catheter approved by the FDA?

speX LP Support Catheter received FDA 510(k) clearance on 2020-03-18, under approval number K200094.

What company makes speX LP Support Catheter?

speX LP Support Catheter is manufactured by Reflow Medical.

What is the FDA product code for speX LP Support Catheter?

The FDA product code for speX LP Support Catheter is DQY.

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Other Devices by Reflow Medical

K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35 K193012speX Support Catheter K210188coraCross

Related Devices (Code: DQY)

K163000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO K160561Boosting CatheterQxmedical, LLC K161546R2P SlenGuideAshitaka Factory of Terumo Corporation K161152Navien Intracranial Support CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.) K162359Surefire Guiding CatheterSurefire Medical, Inc.

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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