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FDA 510(k)

Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System)

K-Number: K223929 · 2023-06-01

ApplicantInnova Vascular, Inc.
Decision Date2023-06-01
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System) is the device name listed in this FDA 510(k) record. The listed applicant is Innova Vascular, Inc.. It received FDA 510(k) clearance on 2023-06-01 under 510(k) number K223929. 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 Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System)?

Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System) is a medical device that received FDA 510(k) clearance on 2023-06-01. The listed applicant is Innova Vascular, Inc.. The 510(k) number is K223929.

When did Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System) receive FDA 510(k) clearance?

Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System) received FDA 510(k) clearance on 2023-06-01, under 510(k) number K223929.

Who is the listed applicant for Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System)?

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

What is the FDA product code for Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System)?

The FDA product code for Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System) is QEW.

Related Clinical Trials

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.

NCT06041594Treating Pulmonary Embolism With Laguna Thrombectomy System (TRUST)RECRUITINGNCT06029491The Pivotal Study of RapidPulseTM Aspiration SystemRECRUITINGNCT07356284Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial StenosisRECRUITINGNCT07571954Efficacy and Safety Evaluation of iNstroke 5F Aspiration Catheter for ThrombectomyNOT_YET_RECRUITINGNCT07685522Vibrato Aspiration System - Simple, Intuitive Approach to Clot Removal in Acute Pulmonary Embolism - a Safety & Feasibility StudyNOT_YET_RECRUITING

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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