CLIRPATH TURBO EXCIMER LASER CATHETERS

Catheter For Crossing Total Occlusions

SPECTRANETICS CORP.

The following data is part of a premarket notification filed by Spectranetics Corp. with the FDA for Clirpath Turbo Excimer Laser Catheters.

Pre-market Notification Details

Device IDK052296
510k NumberK052296
Device Name:CLIRPATH TURBO EXCIMER LASER CATHETERS
ClassificationCatheter For Crossing Total Occlusions
Applicant SPECTRANETICS CORP. 96 TALAMINE CT. Colorado Springs,  CO  80907 -5159
ContactNeil Burris
CorrespondentNeil Burris
SPECTRANETICS CORP. 96 TALAMINE CT. Colorado Springs,  CO  80907 -5159
Product CodePDU  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-23
Decision Date2005-09-02
Summary:summary

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