FDA 510(k)

SENDERO Microcatheter

K-Number: K240384 · 2024-03-08

Decision Date2024-03-08

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SENDERO Microcatheter is a medical device manufactured by Okami Medical, Inc.. It received FDA 510(k) clearance on 2024-03-08 under approval number K240384. 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 SENDERO Microcatheter?

SENDERO Microcatheter is a medical device that received FDA 510(k) clearance on 2024-03-08. It is manufactured by Okami Medical, Inc.. The 510(k) number is K240384.

When was SENDERO Microcatheter approved by the FDA?

SENDERO Microcatheter received FDA 510(k) clearance on 2024-03-08, under approval number K240384.

What company makes SENDERO Microcatheter?

SENDERO Microcatheter is manufactured by Okami Medical, Inc..

What is the FDA product code for SENDERO Microcatheter?

The FDA product code for SENDERO Microcatheter is DQY.

Other Devices by Okami Medical, Inc.

K231600SENDERO Microcatheter K242644SENDERO MAX Delivery Catheter K260508LOBO Vascular Occlusion System

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.