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FDA 510(k)

ISAAC Neurovascular Navigation Catheter

K-Number: K222115 · 2023-01-10

ApplicantMicroVention, Inc.
Decision Date2023-01-10
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ISAAC Neurovascular Navigation Catheter is a medical device manufactured by MicroVention, Inc.. It received FDA 510(k) clearance on 2023-01-10 under approval number K222115. 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 ISAAC Neurovascular Navigation Catheter?

ISAAC Neurovascular Navigation Catheter is a medical device that received FDA 510(k) clearance on 2023-01-10. It is manufactured by MicroVention, Inc.. The 510(k) number is K222115.

When was ISAAC Neurovascular Navigation Catheter approved by the FDA?

ISAAC Neurovascular Navigation Catheter received FDA 510(k) clearance on 2023-01-10, under approval number K222115.

What company makes ISAAC Neurovascular Navigation Catheter?

ISAAC Neurovascular Navigation Catheter is manufactured by MicroVention, Inc..

What is the FDA product code for ISAAC Neurovascular Navigation Catheter?

The FDA product code for ISAAC Neurovascular Navigation Catheter is DQY.

Related Clinical Trials

NCT07593872 XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer NOT_YET_RECRUITING NCT06588543 Patient-specific Planning of Minimally Invasive Brain Interventions Based on Vascular-hemodynamic Mapping RECRUITING NCT07271238 Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures RECRUITING NCT06895187 Catheter Ablation Using a Novel Navigation and Imaging System NOT_YET_RECRUITING NCT07210151 Anatomical Navigation for Guided Electrophysiology in AFL and AFib RECRUITING NCT07516145 Robotic Transjugular Transcatheter Tricuspid Valve Replacement RECRUITING

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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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