CARDIO PERFECT ST 2001— 510(k) K935732

Substantially Equivalent

Cardio Control BV

FDA 510(k) clearance K935732 for CARDIO PERFECT ST 2001, Substantially Equivalent on 1996-04-04. Applicant: Cardio Control BV.

Clearance details

Applicant: Cardio Control BV
Product code: Code DSI
Advisory panel: Cardiovascular
Date received: 1993-12-01
Decision date: 1996-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: The Netherlands, NL

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

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.