SOFIA EX Intracranial Support Catheter— 510(k) K230775

Substantially Equivalent

MicroVention, Inc.

FDA 510(k) clearance K230775 for SOFIA EX Intracranial Support Catheter, Substantially Equivalent on 2023-09-14. Applicant: MicroVention, Inc..

Clearance details

Applicant: MicroVention, Inc.
Product code: Code QJP
Advisory panel: Cardiovascular
Date received: 2023-03-21
Decision date: 2023-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aliso Viejo, CA, US

Download summary PDF View on FDA.gov ↗

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.