Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter— 510(k) K150107

Substantially Equivalent

Micro Therapeutics Inc Dba Ev3 Neurovascular

FDA 510(k) clearance K150107 for Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter, Substantially Equivalent on 2015-07-29. Applicant: Micro Therapeutics Inc Dba Ev3 Neurovascular.

Clearance details

Applicant: Micro Therapeutics Inc Dba Ev3 Neurovascular
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2015-01-20
Decision date: 2015-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.