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FDA 510(k)

Guiding Catheter

K-Number: K210009 · 2021-11-24

ApplicantCenterPoint Systems, LLC
Decision Date2021-11-24
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Guiding Catheter is a medical device manufactured by CenterPoint Systems, LLC. It received FDA 510(k) clearance on 2021-11-24 under approval number K210009. 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 Guiding Catheter?

Guiding Catheter is a medical device that received FDA 510(k) clearance on 2021-11-24. It is manufactured by CenterPoint Systems, LLC. The 510(k) number is K210009.

When was Guiding Catheter approved by the FDA?

Guiding Catheter received FDA 510(k) clearance on 2021-11-24, under approval number K210009.

What company makes Guiding Catheter?

Guiding Catheter is manufactured by CenterPoint Systems, LLC.

What is the FDA product code for Guiding Catheter?

The FDA product code for 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

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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