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Spectranetics Corp.

24 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
LEXICONTURE MECHANICAL DILATOR SHEATH SET (K140047)Spectranetics Corp.2014-04-09
2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035 (K123632)Spectranetics Corp.2013-01-25
8FR TURBO - TANDEM SYSTEM (K112032)Spectranetics Corp.2011-10-17
TORQMAX SHEATH GRIP ACCESSORY (K093257)Spectranetics Corp.2010-03-26
TURBO-TANDEM SYSTEM MODEL 472-110 (K094036)Spectranetics Corp.2010-01-25
SPECTRANETICS VISISHEATH DILATOR SHEATH (K092378)Spectranetics Corp.2009-11-02
SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS (K092396)Spectranetics Corp.2009-09-04
SPECTRANETICS TURBO-TANDEM SYSTEM (K091299)Spectranetics Corp.2009-07-01
CROSS-PILOT TURBO ELITE SUPPORT CATHETER (K090913)Spectranetics Corp.2009-05-04
SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER (K082559)Spectranetics Corp.2008-12-11
SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS (K082561)Spectranetics Corp.2008-12-10
SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066 (K072750)Spectranetics Corp.2007-12-04
CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15 (K071227)Spectranetics Corp.2007-07-11
8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043 (K071226)Spectranetics Corp.2007-06-29
CLIRPATH TURBO PERIPHERAL CATHETERS (K060012)Spectranetics Corp.2006-09-29
CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001 (K052514)Spectranetics Corp.2005-10-19
CLIRPATH TURBO EXCIMER LASER CATHETERS (K052296)Spectranetics Corp.2005-09-02
2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011 (K043465)Spectranetics Corp.2005-08-18
SPECTRANETICS LLD CS, MODEL 518-039 (K043401)Spectranetics Corp.2005-03-16
CLIRPATH EXCIMER LASER CATHETER (K040067)Spectranetics Corp.2004-04-27
SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038 (K033678)Spectranetics Corp.2004-02-23
SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028 (K022138)Spectranetics Corp.2002-09-23
SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-017 (K991059)Spectranetics Corp.1999-11-16
SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER (K990713)Spectranetics Corp.1999-10-22

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Every clearance here is in the API, with alerts when new ones post.