SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-017

Catheter, Percutaneous

SPECTRANETICS CORP.

The following data is part of a premarket notification filed by Spectranetics Corp. with the FDA for Spectranetics 0.014 Support Catheter, Model 518-016, Spectranetics 0.018 Support Catheter, Model 518-017.

Pre-market Notification Details

Device IDK991059
510k NumberK991059
Device Name:SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-017
ClassificationCatheter, Percutaneous
Applicant SPECTRANETICS CORP. 96 TALAMINE CT. Colorado Springs,  CO  80907 -5159
ContactMichael J Quinn
CorrespondentMichael J Quinn
SPECTRANETICS CORP. 96 TALAMINE CT. Colorado Springs,  CO  80907 -5159
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-30
Decision Date1999-11-16
Summary:summary

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