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Spectranetics Corp.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
42
Inspections
0
Compliance Actions
0

Known Names

spectranetics, spectranetics corporation

Recent Recalls

NumberClassProductDate
Z-0758-2016Class II2.3mm Turbo-Power OTW, Manual, Model No 423-050 Product Usage The Turbo-Power System (Laser AtherecJanuary 15, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K250385Turbo-Elite Laser Atherectomy CatheterMarch 13, 2025
K223472TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized DilatoDecember 15, 2022
K222837Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy CathetersDecember 8, 2022
K212784TightRail Guardian Motorized Dilator SheathAugust 24, 2022
DEN210024CavaClear Laser SheathDecember 21, 2021
K203540Bridge Occlusion BalloonDecember 23, 2020
K180694Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy CathetersApril 5, 2018
K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy CathetersNovember 27, 2017
K170059Spectranetics Turbo-Elite Laser Atherectomy CathetersApril 7, 2017
K162561Turbo-Power (2.0mm) Laser Atherectomy CathetersJanuary 5, 2017
K161333TightRail Sub-C Rotating Dilator SheathJuly 8, 2016
K153530Bridge Occlusion BalloonFebruary 5, 2016
K152181Turbo-Power Laser Atherectomy CatheterNovember 12, 2015
K150360TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator SheathMarch 4, 2015
K150201Quick-Cross Extreme Support Catheter, Quick-Cross Select Support CatheterFebruary 27, 2015
K142546TightRail Rotating Dilator Sheath/TightRail Mini Dilator SheathSeptember 25, 2014
K142116LLD EZAugust 12, 2014
K141131TIGHTRAIL MINIMay 23, 2014
K140047LEXICONTURE MECHANICAL DILATOR SHEATH SETApril 9, 2014
K1236322.5MM TURBO ELITE 035, 2.3MM TURBO ELITE 035January 25, 2013