CARDIO MED— 510(k) K103334

Substantially Equivalent

Cardio Medical Products, Inc.

FDA 510(k) clearance K103334 for CARDIO MED, Substantially Equivalent on 2011-01-18. Applicant: Cardio Medical Products, Inc..

Clearance details

Applicant: Cardio Medical Products, Inc.
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 2010-11-15
Decision date: 2011-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockaway, NJ, US

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.