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Spectranetics, Inc.

17 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013) (K223472)Spectranetics, Inc.2022-12-15
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters (K222837)Spectranetics, Inc.2022-12-08
TightRail Guardian Motorized Dilator Sheath (K212784)Spectranetics, Inc.2022-08-24
CavaClear Laser Sheath (DEN210024)Spectranetics, Inc.2021-12-21
Bridge Occlusion Balloon (K203540)Spectranetics, Inc.2020-12-23
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters (K180694)Spectranetics, Inc.2018-04-05
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters (K172687)Spectranetics, Inc.2017-11-27
Spectranetics Turbo-Elite Laser Atherectomy Catheters (K170059)Spectranetics, Inc.2017-04-07
Turbo-Power (2.0mm) Laser Atherectomy Catheters (K162561)Spectranetics, Inc.2017-01-05
TightRail Sub-C Rotating Dilator Sheath (K161333)Spectranetics, Inc.2016-07-08
Bridge Occlusion Balloon (K153530)Spectranetics, Inc.2016-02-05
Turbo-Power Laser Atherectomy Catheter (K152181)Spectranetics, Inc.2015-11-12
TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath (K150360)Spectranetics, Inc.2015-03-04
Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter (K150201)Spectranetics, Inc.2015-02-27
TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath (K142546)Spectranetics, Inc.2014-09-25
LLD EZ (K142116)Spectranetics, Inc.2014-08-12
TIGHTRAIL MINI (K141131)Spectranetics, Inc.2014-05-23

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