Vela RX PTA Balloon Dilatation Catheter— 510(k) K171290

Substantially Equivalent

Curatia Medical

FDA 510(k) clearance K171290 for Vela RX PTA Balloon Dilatation Catheter, Substantially Equivalent on 2017-07-19. Applicant: Curatia Medical.

Clearance details

Applicant: Curatia Medical
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 2017-05-02
Decision date: 2017-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Clara, CA, 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.