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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 the device name listed in this FDA 510(k) record. The listed applicant is Verge Medical, Inc.. It received FDA 510(k) clearance on 2026-01-21 under 510(k) 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. The listed applicant is Verge Medical, Inc.. The 510(k) number is K253730.

When did RoVo Mechanical Thrombectomy System receive FDA 510(k) clearance?

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

Who is the listed applicant for RoVo Mechanical Thrombectomy System?

The FDA 510(k) record lists Verge Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Verge Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254022FLASH Flex™ Aorto-Ostial Angioplasty System

Related Devices (Code: QEW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261523Vertex™ Thrombectomy SystemJupiter EndovascularK260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc.K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration CanisterArgon Medical Devices, Inc.K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.K251207Sangria™ Thrombectomy SystemAvantec Vascular CorporationK252956Helo Thrombectomy SystemEndovascular Engineering, 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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