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FDA 510(k)

Scepter Mini Occlusion Balloon Catheter

K-Number: K182829 · 2019-07-10

ApplicantMicroVention, Inc.
Decision Date2019-07-10
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Scepter Mini Occlusion Balloon Catheter is a medical device manufactured by MicroVention, Inc.. It received FDA 510(k) clearance on 2019-07-10 under approval number K182829. 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 Scepter Mini Occlusion Balloon Catheter?

Scepter Mini Occlusion Balloon Catheter is a medical device that received FDA 510(k) clearance on 2019-07-10. It is manufactured by MicroVention, Inc.. The 510(k) number is K182829.

When was Scepter Mini Occlusion Balloon Catheter approved by the FDA?

Scepter Mini Occlusion Balloon Catheter received FDA 510(k) clearance on 2019-07-10, under approval number K182829.

What company makes Scepter Mini Occlusion Balloon Catheter?

Scepter Mini Occlusion Balloon Catheter is manufactured by MicroVention, Inc..

What is the FDA product code for Scepter Mini Occlusion Balloon Catheter?

The FDA product code for Scepter Mini Occlusion Balloon Catheter is DQY.

Related Clinical Trials

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Related PubMed Literature

PMID: 41114311 From bench to bedside and back: translational cardiovascular interventions in veterinary medicine. Postepy w kardiologii interwencyjnej = Advances in interventional cardiology (2025)

Other Devices by MicroVention, Inc.

K163154Traxcess 7 Mini XSoft Guidewire K161803Traxcess .007 Mini Guidewire K161367HydroCoil Embolic System (HES) K161452MicroPlex Coil System (MCS) - HyperSoft 3D K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES) K162999V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System

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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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