091 Balloon Guide Catheter— 510(k) K231629

Substantially Equivalent

Eosolutions, Corp.

FDA 510(k) clearance K231629 for 091 Balloon Guide Catheter, Substantially Equivalent on 2023-10-31. Applicant: Eosolutions, Corp..

Clearance details

Applicant: Eosolutions, Corp.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2023-06-05
Decision date: 2023-10-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Pembroke Pines, FL, 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.