FDA 510(k)

Xcess Guiding Catheter

K-Number: K180797 · 2018-12-14

Decision Date2018-12-14

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Xcess Guiding Catheter is a medical device manufactured by Curatia Medical Co.. It received FDA 510(k) clearance on 2018-12-14 under approval number K180797. 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 Xcess Guiding Catheter?

Xcess Guiding Catheter is a medical device that received FDA 510(k) clearance on 2018-12-14. It is manufactured by Curatia Medical Co.. The 510(k) number is K180797.

When was Xcess Guiding Catheter approved by the FDA?

Xcess Guiding Catheter received FDA 510(k) clearance on 2018-12-14, under approval number K180797.

What company makes Xcess Guiding Catheter?

Xcess Guiding Catheter is manufactured by Curatia Medical Co..

What is the FDA product code for Xcess Guiding Catheter?

The FDA product code for Xcess Guiding Catheter is DQY.

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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

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