Ballast 088 Long Sheath— 510(k) K182918

Substantially Equivalent

Balt USA, LLC

FDA 510(k) clearance K182918 for Ballast 088 Long Sheath, Substantially Equivalent on 2019-03-21. Applicant: Balt USA, LLC.

Clearance details

Applicant: Balt USA, LLC
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2018-10-19
Decision date: 2019-03-21
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.