Medical Device Manufacturer · US , Colorado Springs , CO

Spectranetics Corp. - FDA 510(k) Cleared Devices

24 submissions · 24 cleared · Since 1999

Recent clearances: LEXICONTURE MECHANICAL DILATOR SHEATH SET, 2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035, 8FR TURBO - TANDEM SYSTEM

24

Total

24

Cleared

0

Denied

FDA 510(k) Regulatory Record - Spectranetics Corp. Cardiovascular ✕

24 devices

1-12 of 24

Cleared Apr 09, 2014

LEXICONTURE MECHANICAL DILATOR SHEATH SET

Cardiovascular · 90d

Cleared Jan 25, 2013

2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035

Cardiovascular · 63d

Cleared Oct 17, 2011

8FR TURBO - TANDEM SYSTEM

Cardiovascular · 94d

Cleared Mar 26, 2010

TORQMAX SHEATH GRIP ACCESSORY

Cardiovascular · 158d

Cleared Jan 25, 2010

TURBO-TANDEM SYSTEM MODEL 472-110

Cardiovascular · 26d

Cleared Nov 02, 2009

SPECTRANETICS VISISHEATH DILATOR SHEATH

Cardiovascular · 89d

Cleared Sep 04, 2009

SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS

Cardiovascular · 30d

Cleared Jul 01, 2009

SPECTRANETICS TURBO-TANDEM SYSTEM

Cardiovascular · 58d

Cleared May 04, 2009

CROSS-PILOT TURBO ELITE SUPPORT CATHETER

Cardiovascular · 33d

Cleared Dec 11, 2008

SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER

Cardiovascular · 98d

Cleared Dec 10, 2008

SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS

Cardiovascular · 97d

Cleared Dec 04, 2007

SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066

Cardiovascular · 68d