8FR TURBO - TANDEM SYSTEM

Catheter, Percutaneous

SPECTRANETICS CORP.

The following data is part of a premarket notification filed by Spectranetics Corp. with the FDA for 8fr Turbo - Tandem System.

Pre-market Notification Details

Device IDK112032
510k NumberK112032
Device Name:8FR TURBO - TANDEM SYSTEM
ClassificationCatheter, Percutaneous
Applicant SPECTRANETICS CORP. 9965 FEDERAL DR. Colorado Springs,  CO  80921
ContactShelley Wilcox
CorrespondentShelley Wilcox
SPECTRANETICS CORP. 9965 FEDERAL DR. Colorado Springs,  CO  80921
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-15
Decision Date2011-10-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M204482110AA0 K112032 000
M2044821100 K112032 000

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