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FDA 510(k)

Sangria™ Thrombectomy System

K-Number: K251207 · 2026-01-07

ApplicantAvantec Vascular Corporation
Decision Date2026-01-07
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sangria™ Thrombectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Avantec Vascular Corporation. It received FDA 510(k) clearance on 2026-01-07 under 510(k) number K251207. 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 Sangria™ Thrombectomy System?

Sangria™ Thrombectomy System is a medical device that received FDA 510(k) clearance on 2026-01-07. The listed applicant is Avantec Vascular Corporation. The 510(k) number is K251207.

When did Sangria™ Thrombectomy System receive FDA 510(k) clearance?

Sangria™ Thrombectomy System received FDA 510(k) clearance on 2026-01-07, under 510(k) number K251207.

Who is the listed applicant for Sangria™ Thrombectomy System?

The FDA 510(k) record lists Avantec Vascular Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sangria™ Thrombectomy System?

The FDA product code for Sangria™ Thrombectomy System is QEW.

Other records listing Avantec Vascular Corporation 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.

K170987Captus Vascular Retrieval 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.K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.K252956Helo 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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