FDA 510(k) Applications Submitted by SPECTRANETICS CORP.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K040067 |
01/14/2004 |
CLIRPATH EXCIMER LASER CATHETER |
SPECTRANETICS CORP. |
| K043465 |
12/15/2004 |
2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011 |
SPECTRANETICS CORP. |
| K090913 |
04/01/2009 |
CROSS-PILOT TURBO ELITE SUPPORT CATHETER |
SPECTRANETICS CORP. |
| K093257 |
10/19/2009 |
TORQMAX SHEATH GRIP ACCESSORY |
SPECTRANETICS CORP. |
| K092378 |
08/05/2009 |
SPECTRANETICS VISISHEATH DILATOR SHEATH |
SPECTRANETICS CORP. |
| K092396 |
08/05/2009 |
SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS |
SPECTRANETICS CORP. |
| K123632 |
11/23/2012 |
2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035 |
SPECTRANETICS CORP. |
| K091299 |
05/04/2009 |
SPECTRANETICS TURBO-TANDEM SYSTEM |
SPECTRANETICS CORP. |
| K990713 |
03/04/1999 |
SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER |
SPECTRANETICS CORP. |
| K991059 |
03/30/1999 |
SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-017 |
SPECTRANETICS CORP. |
| K060012 |
01/03/2006 |
CLIRPATH TURBO PERIPHERAL CATHETERS |
SPECTRANETICS CORP. |
| K022138 |
07/02/2002 |
SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028 |
SPECTRANETICS CORP. |
| K033678 |
11/24/2003 |
SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038 |
SPECTRANETICS CORP. |
| K043401 |
12/10/2004 |
SPECTRANETICS LLD CS, MODEL 518-039 |
SPECTRANETICS CORP. |
| K071226 |
05/03/2007 |
8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043 |
SPECTRANETICS CORP. |
| K071227 |
05/03/2007 |
CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15 |
SPECTRANETICS CORP. |
| K082559 |
09/04/2008 |
SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER |
SPECTRANETICS CORP. |
| K082561 |
09/04/2008 |
SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS |
SPECTRANETICS CORP. |
| K072750 |
09/27/2007 |
SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066 |
SPECTRANETICS CORP. |
| K094036 |
12/30/2009 |
TURBO-TANDEM SYSTEM MODEL 472-110 |
SPECTRANETICS CORP. |
| K052296 |
08/23/2005 |
CLIRPATH TURBO EXCIMER LASER CATHETERS |
SPECTRANETICS CORP. |
| K052514 |
09/14/2005 |
CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001 |
SPECTRANETICS CORP. |
| K140047 |
01/09/2014 |
LEXICONTURE MECHANICAL DILATOR SHEATH SET |
SPECTRANETICS CORP. |
| K112032 |
07/15/2011 |
8FR TURBO - TANDEM SYSTEM |
SPECTRANETICS CORP. |
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