Laguna Clot Retriever System and Malibu Aspiration Catheter System (Laguna Thrombectomy System)— 510(k) K223929

Substantially Equivalent

Innova Vascular, Inc.

FDA 510(k) clearance K223929 for Laguna Clot Retriever System and Malibu Aspiration Catheter System (Laguna Thrombectomy System), Substantially Equivalent on 2023-06-01. Applicant: Innova Vascular, Inc..

Clearance details

Applicant: Innova Vascular, Inc.
Product code: Code QEW
Advisory panel: Cardiovascular
Date received: 2022-12-30
Decision date: 2023-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QEW

product code QEW

Death: 126
Injury: 282
Malfunction: 820
Total: 1,228

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.