510(k) K112335— BANTAM CATHETER (280MM BALLOON LENGTHS)

Substantially Equivalent

ClearStream Technologies , Ltd.

Clearance details

Applicant: ClearStream Technologies , Ltd.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2011-08-12
Decision date: 2011-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wexford, IE

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.