FDA 510(k) Applications Submitted by SPECTRANETICS, INC.

FDA 510(k) Number	Submission Date	Device Name	Applicant
K150201	01/29/2015	Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter	SPECTRANETICS, INC.
K141131	05/01/2014	TIGHTRAIL MINI	SPECTRANETICS, INC.
K142546	09/10/2014	TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath	SPECTRANETICS, INC.
K153530	12/09/2015	Bridge Occlusion Balloon	SPECTRANETICS, INC.
K150360	02/12/2015	TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath	SPECTRANETICS, INC.
K212784	09/01/2021	TightRail Guardian Motorized Dilator Sheath	Spectranetics, Inc.
K142116	08/04/2014	LLD EZ	SPECTRANETICS, INC.
K152181	08/04/2015	Turbo-Power Laser Atherectomy Catheter	SPECTRANETICS, INC.
K162561	09/14/2016	Turbo-Power (2.0mm) Laser Atherectomy Catheters	SPECTRANETICS, INC.
K170059	01/06/2017	Spectranetics Turbo-Elite Laser Atherectomy Catheters	Spectranetics, Inc.
DEN210024	06/25/2021	CavaClear Laser Sheath	Spectranetics, Inc.
K203540	12/03/2020	Bridge Occlusion Balloon	Spectranetics, Inc.
K161333	05/12/2016	TightRail Sub-C Rotating Dilator Sheath	Spectranetics, Inc.
K172687	09/06/2017	Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters	Spectranetics, Inc.
K180694	03/16/2018	Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters	Spectranetics, Inc.