FDA applicant
Cardio-Vascular Innovations, Inc.
FDA records 4 decisions for Cardio-Vascular Innovations, Inc. (Chantilly, VA) from 1984 to 1987: 4 510(k) clearances. Most are in product codes DQY (Catheter, Percutaneous) and DYB (Introducer, Catheter). 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 Cardio-Vascular Innovations, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Cardio-Vascular Innovations, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Cardio-Vascular Innovations, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report