Optima Coil System (Optima Packing Coil System)— 510(k) K252700

Substantially Equivalent

Balt USA, LLC

FDA 510(k) clearance K252700 for Optima Coil System (Optima Packing Coil System), Substantially Equivalent on 2025-09-26. Applicant: Balt USA, LLC.

Clearance details

Applicant: Balt USA, LLC
Product code: Code HCG
Advisory panel: Neurology
Date received: 2025-08-27
Decision date: 2025-09-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HCG

product code HCG

Death: 50
Injury: 801
Malfunction: 5,625
Total: 6,476

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.