EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC— 510(k) K103783

Substantially Equivalent

Fiab Spa

FDA 510(k) clearance K103783 for EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC, Substantially Equivalent on 2011-06-16. Applicant: Fiab Spa.

Clearance details

Applicant: Fiab Spa
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 2010-12-27
Decision date: 2011-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vicchio Florence, IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code LDD

product code LDD

Death: 38
Malfunction: 522
Total: 560

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.