510(k) Report

FDA applicant

Ppg Hellige B.V.

West Germany, DE3 decisions1991–19930 recalls

FDA records 3 decisions for Ppg Hellige B.V. (West Germany, DE) from 1991 to 1993: 3 510(k) clearances. Most are in product codes LDD (Dc-Defibrillator, Low-Energy, (Including…) and DSP (System, Balloon, Intra-Aortic And Control). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Ppg Hellige B.V.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ppg Hellige B.V. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ppg Hellige B.V. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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