Medical Device Manufacturer · US , Colorado Springs , CO

Spectranetics Corporation - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2014

Recent clearances: TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM, LEXIPLIANT DILATOR SHEATH SET

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Spectranetics Corporation Cardiovascular ✕

2 devices

1-2 of 2

Cleared CT Jul 23, 2014

TURBO-ELITE ATHERECTOMY CATHETERS, TURBO TANDEM SYSTEM

Cardiovascular · 117d

Cleared Mar 27, 2014

LEXIPLIANT DILATOR SHEATH SET

Cardiovascular · 121d

Data Source

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

Last updated: Sep 20, 2026