FDA applicant
Premier Heart, LLC
FDA records 1 decision for Premier Heart, LLC (Washington, DC) in 2000: 1 510(k) clearance. All are in product code DQK (Computer, Diagnostic, Programmable). 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 Premier Heart, LLC’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Premier Heart, LLC since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Premier Heart, LLC’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