Spectranetics Corp.

FDA 510(k) & PMA Approved Devices — 23 products

Total Devices23

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K123632	2.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035	MCW	2013-01-25	View
510(k)	K112032	8FR TURBO - TANDEM SYSTEM	DQY	2011-10-17	View
510(k)	K093257	TORQMAX SHEATH GRIP ACCESSORY	OFC	2010-03-26	View
510(k)	K094036	TURBO-TANDEM SYSTEM MODEL 472-110	MCW	2010-01-25	View
510(k)	K092378	SPECTRANETICS VISISHEATH DILATOR SHEATH	DRE	2009-11-02	View
510(k)	K092396	SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS	DQY	2009-09-04	View
510(k)	K091299	SPECTRANETICS TURBO-TANDEM SYSTEM	DQY	2009-07-01	View
510(k)	K090913	CROSS-PILOT TURBO ELITE SUPPORT CATHETER	DQY	2009-05-04	View
510(k)	K082559	SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER	DQY	2008-12-11	View
510(k)	K082561	SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS	DQY	2008-12-10	View
510(k)	K072750	SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066	DQY	2007-12-04	View
510(k)	K071227	CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15	PDU	2007-07-11	View
510(k)	K071226	8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043	PDU	2007-06-29	View
510(k)	K060012	CLIRPATH TURBO PERIPHERAL CATHETERS	PDU	2006-09-29	View
510(k)	K052514	CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001	PDU	2005-10-19	View
510(k)	K052296	CLIRPATH TURBO EXCIMER LASER CATHETERS	PDU	2005-09-02	View
510(k)	K043465	2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011	PDU	2005-08-18	View
510(k)	K043401	SPECTRANETICS LLD CS, MODEL 518-039	DRB	2005-03-16	View
510(k)	K040067	CLIRPATH EXCIMER LASER CATHETER	PDU	2004-04-27	View
510(k)	K033678	SPECTRANETICS QUICK CROSS CATHETERS, MODELS 518-032, 518-033, 518034, 518-035, 518-036, 518-037 AND 518-038	DQY	2004-02-23	View