Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter— 510(k) K192558

Substantially Equivalent

Mivi Neurovascular

FDA 510(k) clearance K192558 for Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter, Substantially Equivalent on 2020-04-06. Applicant: Mivi Neurovascular.

Clearance details

Applicant: Mivi Neurovascular
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2019-09-17
Decision date: 2020-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prarie, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.