MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM— 510(k) K062302

Substantially Equivalent

Millicore AB

FDA 510(k) clearance K062302 for MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM, Substantially Equivalent on 2006-10-06. Applicant: Millicore AB.

Clearance details

Applicant: Millicore AB
Product code: Code KDQ
Advisory panel: General Hospital
Date received: 2006-08-08
Decision date: 2006-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

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Adverse events under product code KDQ

product code KDQ

Death: 8
Malfunction: 637
Total: 645

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.