Medical Device Manufacturer · US , Maple Grove , MN

Piraeus Medical, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2026

Recent clearances: 70 NeuGlide Catheter, 35 Helix Guidewire

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Piraeus Medical, Inc. Neurology ✕

2 devices

1-2 of 2

Cleared Sep 04, 2026

70 NeuGlide Catheter

Neurology · 60d

Cleared Aug 27, 2026

35 Helix Guidewire

Neurology · 174d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Oct 05, 2026