Medical Device Manufacturer · US , Colorado Springs , CO

Spectranetrics - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2015

Recent clearances: AngioSculpt PTA Scoring Baloon Catheters

View 1 510(k) Devices ↓

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Spectranetrics Cardiovascular ✕

1 devices

1-1 of 1

Cleared Apr 08, 2015

AngioSculpt PTA Scoring Baloon Catheters

Cardiovascular · 28d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 22, 2026