CARDIAC THERAPHY SYSTEM SCP 900— 510(k) K921666

Substantially Equivalent

Ppg Hellige B.V.

FDA 510(k) clearance K921666 for CARDIAC THERAPHY SYSTEM SCP 900, Substantially Equivalent on 1993-09-23. Applicant: Ppg Hellige B.V..

Clearance details

Applicant: Ppg Hellige B.V.
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 1992-04-07
Decision date: 1993-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

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.