FDA applicant
Cardiovascular Diagnostic Services
FDA records 8 decisions for Cardiovascular Diagnostic Services (Research Triangle Park, NC) from 1981 to 1996: 8 510(k) clearances. Most are in product codes GJS (Test, Time, Prothrombin) and MAV (Syringe, Balloon Inflation). Its devices cite 1 predicate, 1 of them its own earlier devices. 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 Cardiovascular Diagnostic Services’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Cardiovascular Diagnostic Services since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Cardiovascular Diagnostic Services’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) ReportOther applicant names beginning “Cardiovascular”
FDA records each applicant name separately; these may or may not be the same firm.