Spectranetics, Inc. - FDA 510(k) Cleared Devices
17
Total
16
Cleared
1
Denied
FDA 510(k) cleared devices by Spectranetics, Inc. Cardiovascular ✕
17 devices
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
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
Cleared
Mar 04, 2015
TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath
Cardiovascular
20d
Cleared
Feb 27, 2015
Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter
Cardiovascular
29d
Cleared
Sep 25, 2014
TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath
Cardiovascular
15d
Cleared
Aug 12, 2014
LLD EZ
Cardiovascular
8d
Cleared
May 23, 2014
TIGHTRAIL MINI
Cardiovascular
22d