Medical Device Manufacturer · US , Colorado Springs , CO

Spectranetics Corp. - FDA 510(k) Cleared Devices

24 submissions · 24 cleared · Since 1999

24

Total

24

Cleared

0

Denied

Spectranetics Corp. — FDA 510(k) Products and Clearance History Cardiovascular ✕

24 devices

1-24 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

Cleared Jul 11, 2007

CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM,...

Cardiovascular · 69d

Cleared Jun 29, 2007

8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043

Cardiovascular · 57d

Cleared Sep 29, 2006

CLIRPATH TURBO PERIPHERAL CATHETERS

Cardiovascular · 269d

Cleared Oct 19, 2005

CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159,...

Cardiovascular · 35d

Cleared Sep 02, 2005

CLIRPATH TURBO EXCIMER LASER CATHETERS

Cardiovascular · 10d

Cleared Aug 18, 2005

2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011

Cardiovascular · 246d

Cleared Mar 16, 2005

SPECTRANETICS LLD CS, MODEL 518-039

Cardiovascular · 96d

Cleared Apr 27, 2004

CLIRPATH EXCIMER LASER CATHETER

Cardiovascular · 104d

Cleared Feb 23, 2004

SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034,...

Cardiovascular · 91d

Cleared Sep 23, 2002

SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028

Cardiovascular · 83d

Cleared Nov 16, 1999

SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018...

Cardiovascular · 231d

Cleared Oct 22, 1999

SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER

Cardiovascular · 232d