FDA 510(k) Applications Submitted by SPECTRANETICS, INC.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K150201 |
01/29/2015 |
Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter |
SPECTRANETICS, INC. |
K141131 |
05/01/2014 |
TIGHTRAIL MINI |
SPECTRANETICS, INC. |
K142546 |
09/10/2014 |
TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath |
SPECTRANETICS, INC. |
K153530 |
12/09/2015 |
Bridge Occlusion Balloon |
SPECTRANETICS, INC. |
K150360 |
02/12/2015 |
TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath |
SPECTRANETICS, INC. |
K212784 |
09/01/2021 |
TightRail Guardian Motorized Dilator Sheath |
Spectranetics, Inc. |
K142116 |
08/04/2014 |
LLD EZ |
SPECTRANETICS, INC. |
K152181 |
08/04/2015 |
Turbo-Power Laser Atherectomy Catheter |
SPECTRANETICS, INC. |
K162561 |
09/14/2016 |
Turbo-Power (2.0mm) Laser Atherectomy Catheters |
SPECTRANETICS, INC. |
K170059 |
01/06/2017 |
Spectranetics Turbo-Elite Laser Atherectomy Catheters |
Spectranetics, Inc. |
DEN210024 |
06/25/2021 |
CavaClear Laser Sheath |
Spectranetics, Inc. |
K203540 |
12/03/2020 |
Bridge Occlusion Balloon |
Spectranetics, Inc. |
K161333 |
05/12/2016 |
TightRail Sub-C Rotating Dilator Sheath |
Spectranetics, Inc. |
K172687 |
09/06/2017 |
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters |
Spectranetics, Inc. |
K180694 |
03/16/2018 |
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters |
Spectranetics, Inc. |
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