Raptor Aspiration Catheter; Balt Aspiration Tubing Set— 510(k) K243948

Substantially Equivalent

Balt USA, LLC

FDA 510(k) clearance K243948 for Raptor Aspiration Catheter; Balt Aspiration Tubing Set, Substantially Equivalent on 2025-06-03. Applicant: Balt USA, LLC.

Clearance details

Applicant: Balt USA, LLC
Product code: Code NRY
Advisory panel: Cardiovascular
Date received: 2024-12-23
Decision date: 2025-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NRY

product code NRY

Death: 411
Injury: 1,712
Malfunction: 1,855
Total: 3,978

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.