Medical Device Manufacturer · US , Colorado Springs , CO

Spectranetics, Inc. - FDA 510(k) Cleared Devices

17 submissions · 16 cleared · Since 2014

Recent clearances: TightRail Guardian Motorized Dilator Sheath, 9 French (575-009), Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters, TightRail Guardian Motorized Dilator Sheath

17

Total

16

Cleared

1

Denied

FDA 510(k) Regulatory Record - Spectranetics, Inc. Cardiovascular ✕

17 devices

1-12 of 17

Cleared Dec 15, 2022

TightRail Guardian Motorized Dilator Sheath, 9 French (575-009)

Cardiovascular · 28d

Cleared Dec 08, 2022

Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser...

Cardiovascular · 79d

Cleared Aug 24, 2022

TightRail Guardian Motorized Dilator Sheath

Cardiovascular · 357d

Not Cleared Dec 21, 2021

CavaClear Laser Sheath

DEN210024 · QRJ

Cardiovascular · 179d

Cleared Dec 23, 2020

Bridge Occlusion Balloon

Cardiovascular · 20d

Cleared Apr 05, 2018

Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser...

Cardiovascular · 20d

Cleared Nov 27, 2017

Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser...

Cardiovascular · 82d

Cleared Apr 07, 2017

Spectranetics Turbo-Elite Laser Atherectomy Catheters

Cardiovascular · 91d

Cleared Jan 05, 2017

Turbo-Power (2.0mm) Laser Atherectomy Catheters

Cardiovascular · 113d

Cleared Jul 08, 2016

TightRail Sub-C Rotating Dilator Sheath

Cardiovascular · 57d

Cleared Feb 05, 2016

Bridge Occlusion Balloon

Cardiovascular · 58d

Cleared Nov 12, 2015

Turbo-Power Laser Atherectomy Catheter

Cardiovascular · 100d