CARDIO MED MODEL A102, H104, O101, P103, AND Z100— 510(k) K103159

Substantially Equivalent

Cardio Medical Products, Inc.

FDA 510(k) clearance K103159 for CARDIO MED MODEL A102, H104, O101, P103, AND Z100, Substantially Equivalent on 2011-01-11. Applicant: Cardio Medical Products, Inc..

Clearance details

Applicant: Cardio Medical Products, Inc.
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 2010-10-26
Decision date: 2011-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockaway, NJ, US

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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.