510(k) Report

FDA applicant

Vascucare, Inc.

Orangeburg, NY3 decisions1988–19890 recalls

FDA records 3 decisions for Vascucare, Inc. (Orangeburg, NY) from 1988 to 1989: 3 510(k) clearances. Most are in product codes DWB (Pump, Blood, Cardiopulmonary Bypass, Roller Type) and BZQ (Monitor, Breathing Frequency). 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 Vascucare, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vascucare, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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