CARDIOSMART— 510(k) K950989

Substantially Equivalent

Hellige GmbH

FDA 510(k) clearance K950989 for CARDIOSMART, Substantially Equivalent on 1996-05-13. Applicant: Hellige GmbH.

Clearance details

Applicant: Hellige GmbH
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1995-03-03
Decision date: 1996-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: D7800 Freiburg Im Breisga, DE

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.