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FDA 510(k)

MegaVac Mechanical Thrombectomy System

K-Number: K171493 · 2017-08-10

ApplicantCapture Vascular, Inc.
Decision Date2017-08-10
Product CodeQEX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MegaVac Mechanical Thrombectomy System is a medical device manufactured by Capture Vascular, Inc.. It received FDA 510(k) clearance on 2017-08-10 under approval number K171493. The device is classified under product code QEX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MegaVac Mechanical Thrombectomy System?

MegaVac Mechanical Thrombectomy System is a medical device that received FDA 510(k) clearance on 2017-08-10. It is manufactured by Capture Vascular, Inc.. The 510(k) number is K171493.

When was MegaVac Mechanical Thrombectomy System approved by the FDA?

MegaVac Mechanical Thrombectomy System received FDA 510(k) clearance on 2017-08-10, under approval number K171493.

What company makes MegaVac Mechanical Thrombectomy System?

MegaVac Mechanical Thrombectomy System is manufactured by Capture Vascular, Inc..

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

The FDA product code for MegaVac Mechanical Thrombectomy System is QEX.

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)

Related Devices (Code: QEX)

K163618INDIGO Aspiration SystemPenumbra, Inc. K253407NeVa PV Thrombectomy DeviceVesalio, 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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