TURBO-TANDEM SYSTEM MODEL 472-110

Catheter, Peripheral, Atherectomy

SPECTRANETICS CORP.

The following data is part of a premarket notification filed by Spectranetics Corp. with the FDA for Turbo-tandem System Model 472-110.

Pre-market Notification Details

Device IDK094036
510k NumberK094036
Device Name:TURBO-TANDEM SYSTEM MODEL 472-110
ClassificationCatheter, Peripheral, Atherectomy
Applicant SPECTRANETICS CORP. 9965 Federal Drive Colorado Springs,  CO  80921
ContactMichael K Handley
CorrespondentMichael K Handley
SPECTRANETICS CORP. 9965 Federal Drive Colorado Springs,  CO  80921
Product CodeMCW  
CFR Regulation Number870.4875 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-30
Decision Date2010-01-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M204472110AA0 K094036 000
M2044721100 K094036 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.