Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

RoVo Mechanical Thrombectomy System

K-Number: K253730 · 2026-01-21

ApplicantVerge Medical, Inc.
Decision Date2026-01-21
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RoVo Mechanical Thrombectomy System is a medical device manufactured by Verge Medical, Inc.. It received FDA 510(k) clearance on 2026-01-21 under approval number K253730. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RoVo Mechanical Thrombectomy System?

RoVo Mechanical Thrombectomy System is a medical device that received FDA 510(k) clearance on 2026-01-21. It is manufactured by Verge Medical, Inc.. The 510(k) number is K253730.

When was RoVo Mechanical Thrombectomy System approved by the FDA?

RoVo Mechanical Thrombectomy System received FDA 510(k) clearance on 2026-01-21, under approval number K253730.

What company makes RoVo Mechanical Thrombectomy System?

RoVo Mechanical Thrombectomy System is manufactured by Verge Medical, Inc..

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

The FDA product code for RoVo Mechanical Thrombectomy System is QEW.

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: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024)

Other Devices by Verge Medical, Inc.

K254022FLASH Flex™ Aorto-Ostial Angioplasty System

Related Devices (Code: QEW)

K162970FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter, Retraction AspiratorInari Medical K161506Penumbra Aspiration SystemPenumbra, Inc. K161523INDIGO Aspiration SystemPenumbra, Inc. K160533Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc. K173470ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever SheathInari Medical K163549ClotTriever Thrombectomy SystemInari 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.

↑