K935083

Substantially Equivalent - Subject to Tracking Reg.

PEDIATRIC DEFIB K-PADS

Applicant: Katecho, Inc.
Product code: LDD
Advisory panel: Cardiovascular
Date received: 1993-10-25
Decision date: 1994-07-25
Decision: Substantially Equivalent - Subject to Tracking Reg.
Clearance type: Traditional
Location: Des Moines, IA, US

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.