PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ)— 510(k) K201246

Substantially Equivalent

Qualimed USA, LLC

FDA 510(k) clearance K201246 for PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ), Substantially Equivalent on 2021-08-03. Applicant: Qualimed USA, LLC.

Clearance details

Applicant: Qualimed USA, LLC
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 2020-05-08
Decision date: 2021-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlotte, NC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

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.