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FDA 510(k)

Excipio LV Prime Thrombectomy Device

K-Number: K251485 · 2025-06-13

ApplicantContego Medical, Inc.
Decision Date2025-06-13
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Excipio LV Prime Thrombectomy Device is the device name listed in this FDA 510(k) record. The listed applicant is Contego Medical, Inc.. It received FDA 510(k) clearance on 2025-06-13 under 510(k) number K251485. 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 Excipio LV Prime Thrombectomy Device?

Excipio LV Prime Thrombectomy Device is a medical device that received FDA 510(k) clearance on 2025-06-13. The listed applicant is Contego Medical, Inc.. The 510(k) number is K251485.

When did Excipio LV Prime Thrombectomy Device receive FDA 510(k) clearance?

Excipio LV Prime Thrombectomy Device received FDA 510(k) clearance on 2025-06-13, under 510(k) number K251485.

Who is the listed applicant for Excipio LV Prime Thrombectomy Device?

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

What is the FDA product code for Excipio LV Prime Thrombectomy Device?

The FDA product code for Excipio LV Prime Thrombectomy Device is QEW.

Other records listing Contego 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.

PMA P240009Stent, carotidK230030Excipio SV Aspiration Catheter and TubingK223897Excipio LV Thrombectomy DeviceK221204Excipio SV Thrombectomy DeviceK221339Paladin Carotid Post-Dilation Balloon System with Integrated Embolic ProtectionK181529Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection

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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.K251207Sangria™ Thrombectomy SystemAvantec Vascular Corporation

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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