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

Catheter, Peripheral, Atherectomy

Spectranetics, Inc.

The following data is part of a premarket notification filed by Spectranetics, Inc. with the FDA for Turbo-power (2.0mm) Laser Atherectomy Catheters, Turbo-power (2.3mm) Laser Atherectomy Catheters.

Pre-market Notification Details

Device IDK180694
510k NumberK180694
Device Name:Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
ClassificationCatheter, Peripheral, Atherectomy
Applicant Spectranetics, Inc. 9965 Federal Drive Colorado Springs,  CO  80921
ContactTravis Pittman
CorrespondentTravis Pittman
Spectranetics, Inc. 9965 Federal Drive Colorado Springs,  CO  80921
Product CodeMCW  
CFR Regulation Number870.4875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-16
Decision Date2018-04-05
Summary:summary

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