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FDA 510(k)

Octane Mechanical Thrombectomy System

K-Number: K182232 · 2018-09-11

ApplicantVascular Solutions, Inc.
Decision Date2018-09-11
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Octane Mechanical Thrombectomy System is a medical device manufactured by Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2018-09-11 under approval number K182232. The device is classified under product code QEZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Octane Mechanical Thrombectomy System?

Octane Mechanical Thrombectomy System is a medical device that received FDA 510(k) clearance on 2018-09-11. It is manufactured by Vascular Solutions, Inc.. The 510(k) number is K182232.

When was Octane Mechanical Thrombectomy System approved by the FDA?

Octane Mechanical Thrombectomy System received FDA 510(k) clearance on 2018-09-11, under approval number K182232.

What company makes Octane Mechanical Thrombectomy System?

Octane Mechanical Thrombectomy System is manufactured by Vascular Solutions, Inc..

What is the FDA product code for Octane Mechanical Thrombectomy System?

The FDA product code for Octane Mechanical Thrombectomy System is QEZ.

Related Clinical Trials

NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT07608939 Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers NOT_YET_RECRUITING NCT06871683 ClotTriever® Thrombectomy System Use-Result Survey in Japan RECRUITING NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT06472518 Pharmaco Mechanical Thrombolysis Associated With Anticoagulation Compared With Anticoagulation in the Acute Phase of Very Symptomatic Proximal Venous Thrombosis of the Lower Limbs. RECRUITING NCT07603700 STRATEGY-PE: Real-World Treatment Strategies for Intermediate-High Risk Pulmonary Embolism NOT_YET_RECRUITING

Related PubMed Literature

PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Vascular Solutions, Inc.

K161702Endura guidewire K162272Fluent inflation device K161336VSI StraitSet micro-introducer kit K173532Raider Guidewire K173266Octane aspiration system K170544Langston dual lumen catheter

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Related Devices (Code: QEZ)

K161786ClearLumen II Thrombectomy SystemWalk Vascular, LLC K173266Octane aspiration systemVascular Solutions, Inc. K172000ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC K163051ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC K192439JETi Peripheral Thrombectomy SystemWalk Vascular, LLC K190619Aspiron(TM) Aspiration CatheterMeril Life Sciences Private Limited

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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