FDA applicant
Vascucare, Inc.
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
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.
Planning a device like Vascucare, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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