Medical Device Manufacturer · US , Hudson , NH

Kaneka Pharma America, LLC - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2010

Recent clearances: i-ED COIL, Lacriflow CL, XPRESSWAY RX CATHETER (6F LD-VERISON)

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Kaneka Pharma America, LLC Cardiovascular ✕

2 devices

1-2 of 2

Cleared Jul 30, 2012

XPRESSWAY RX CATHETER (6F LD-VERISON)

Cardiovascular · 90d

Cleared Oct 22, 2010

KANEKA PHARMA AMERICA XPRESS-WAY RX

Cardiovascular · 113d

Data Source

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

Last updated: May 28, 2026