Piraeus Medical is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Piraeus Medical - FDA 510(k) Cleared Devices
Recent clearances: 93 NeuFlex Catheter, 87 NeuGlide Catheter
2
Total
2
Cleared
0
Denied
Piraeus Medical, is a medical device company focused on Neurology devices. The company operates with a manufacturing facility in Maple Grove, Minnesota.
Piraeus Medical has received 2 FDA 510(k) clearances from 2 total submissions. The company specializes exclusively in Neurology devices. Its regulatory activity spans from 2024 to 2025, demonstrating ongoing FDA engagement and recent market clearances.
Recent cleared devices include catheter systems designed for neurological applications. The company maintains active regulatory status with clearances within the past two years.
Explore the company's cleared device names, product codes, and specific clearance dates in the database.
FDA 510(k) Regulatory Record - Piraeus Medical
2 devices