Vector PTA Balloon Dilatation Catheter— 510(k) K143652

Substantially Equivalent

Vector Corporation, LLC

FDA 510(k) clearance K143652 for Vector PTA Balloon Dilatation Catheter, Substantially Equivalent on 2015-02-26. Applicant: Vector Corporation, LLC.

Clearance details

Applicant: Vector Corporation, LLC
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 2014-12-23
Decision date: 2015-02-26
Decision: Substantially Equivalent
Clearance type: Special
Location: New York, NY, 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.