Spectranetics Inc

FDA Filings

This page includes the latest FDA filings for Spectranetics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
PMN K222837 Spectranetics Inc.	Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters	2022-12-08
PMN K212784 Spectranetics, Inc.	TightRail Guardian Motorized Dilator Sheath	2022-08-24
De Novo DEN210024 Spectranetics, Inc.	CavaClear Laser Sheath	2021-12-21
PMN K203540 Spectranetics, Inc.	Bridge Occlusion Balloon	2020-12-23
PMN K180694 Spectranetics, Inc.	Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters	2018-04-05
PMN K172687 Spectranetics, Inc.	Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters	2017-11-27
PMN K170059 Spectranetics, Inc.	Spectranetics Turbo-Elite Laser Atherectomy Catheters	2017-04-07
PMN K162561 SPECTRANETICS, INC.	Turbo-Power (2.0mm) Laser Atherectomy Catheters	2017-01-05
PMN K161333 Spectranetics, Inc.	TightRail Sub-C Rotating Dilator Sheath	2016-07-08
PMN K153530 SPECTRANETICS, INC.	Bridge Occlusion Balloon	2016-02-05
PMN K152181 SPECTRANETICS, INC.	Turbo-Power Laser Atherectomy Catheter	2015-11-12
PMN K150360 SPECTRANETICS, INC.	TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath	2015-03-04
PMN K150201 SPECTRANETICS, INC.	Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter	2015-02-27
PMN K142546 SPECTRANETICS, INC.	TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath	2014-09-25
PMN K142116 SPECTRANETICS, INC.	LLD EZ	2014-08-12
PMN K141131 SPECTRANETICS, INC.	TIGHTRAIL MINI	2014-05-23

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018112234542	Anvers,Belgium -> Houston, Texas	FIBRE DRAW TOWER FIBRE DRAW TOWER (PARTS) HS-CODE 84649000 REF. PO 21801684 + PO 21803973 FREIGHT PREPAID	5 PCS