CARDIO SERV— 510(k) K951110

Substantially Equivalent

Hellige GmbH

FDA 510(k) clearance K951110 for CARDIO SERV, Substantially Equivalent on 1995-09-15. Applicant: Hellige GmbH.

Clearance details

Applicant: Hellige GmbH
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 1995-03-10
Decision date: 1995-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: D7800 Freiburg Im Breisga, DE

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.