K241388

Substantially Equivalent

Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective Catheter

Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Product code: QJP
Advisory panel: Cardiovascular
Date received: 2024-05-15
Decision date: 2025-01-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, 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.