510(k) K261808— ISAAC Neurovascular Navigation Catheter

Substantially Equivalent

Microvention Inc. d/b/a Terumo Neuro

Clearance details

Applicant: Microvention Inc. d/b/a Terumo Neuro
Product code: Code QJP
Advisory panel: Cardiovascular
Date received: 2026-06-01
Decision date: 2026-06-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Aliso Viejo, CA, US

Adverse events under product code QJP

product code QJP

Death: 43
Injury: 233
Malfunction: 1,010
Total: 1,286

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.