Medical Device Manufacturer · US , Colorado Springs , CO

Spectranetics, Inc.

17 submissions · 16 cleared · Since 2014
17
Total
16
Cleared
1
Denied

Spectranetics, Inc. — FDA 510(k) Submissions

Spectranetics, Inc. has submitted 17 FDA 510(k) premarket notifications since 2014, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Dilator, Vessel, For Percutaneous Catheterization, Catheter, Peripheral, Atherectomy, Catheter, Intravascular Occluding, Temporary, Laser-powered Inferior Vena Cava Filter Retrieval Catheter, Stylet, Catheter . Use the specialty filter in the sidebar to narrow results.

17 devices
1–17 of 17
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 · DRE Dilator, Vessel, For... · Cardiovascular
Dec 2022 28d
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
K222837 · MCW Catheter, Peripheral,... · Cardiovascular
Dec 2022 79d
TightRail Guardian Motorized Dilator Sheath
K212784 · DRE Dilator, Vessel, For... · Cardiovascular
Aug 2022 357d
CavaClear Laser Sheath
DEN210024 · QRJ Laser-powered Inferior... · Cardiovascular
Dec 2021 179d
Bridge Occlusion Balloon
K203540 · MJN Catheter, Intravascular... · Cardiovascular
Dec 2020 20d
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
K180694 · MCW Catheter, Peripheral,... · Cardiovascular
Apr 2018 20d
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
K172687 · MCW Catheter, Peripheral,... · Cardiovascular
Nov 2017 82d
Spectranetics Turbo-Elite Laser Atherectomy Catheters
K170059 · MCW Catheter, Peripheral,... · Cardiovascular
Apr 2017 91d
Turbo-Power (2.0mm) Laser Atherectomy Catheters
K162561 · MCW Catheter, Peripheral,... · Cardiovascular
Jan 2017 113d
TightRail Sub-C Rotating Dilator Sheath
K161333 · DRE Dilator, Vessel, For... · Cardiovascular
Jul 2016 57d
Bridge Occlusion Balloon
K153530 · MJN Catheter, Intravascular... · Cardiovascular
Feb 2016 58d
Turbo-Power Laser Atherectomy Catheter
K152181 · MCW Catheter, Peripheral,... · Cardiovascular
Nov 2015 100d
TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath
K150360 · DRE Dilator, Vessel, For... · Cardiovascular
Mar 2015 20d
Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter
K150201 · DQY Catheter, Percutaneous · Cardiovascular
Feb 2015 29d
TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath
K142546 · DRE Dilator, Vessel, For... · Cardiovascular
Sep 2014 15d
LLD EZ
K142116 · DRB Stylet, Catheter · Cardiovascular
Aug 2014 8d
TIGHTRAIL MINI
K141131 · DRE Dilator, Vessel, For... · Cardiovascular
May 2014 22d
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