LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES

Catheter For Crossing Total Occlusions

LUMEND, INC.

The following data is part of a premarket notification filed by Lumend, Inc. with the FDA for Lumend Frontrunner Cto Catheter And Accessories.

Pre-market Notification Details

Device IDK033535
510k NumberK033535
Device Name:LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES
ClassificationCatheter For Crossing Total Occlusions
Applicant LUMEND, INC. 400 CHESAPEAKE DR. Redwood City,  CA  94063
ContactMichael A Daniel
CorrespondentMichael A Daniel
LUMEND, INC. 400 CHESAPEAKE DR. Redwood City,  CA  94063
Product CodePDU  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-11-10
Decision Date2004-01-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20705032028445 K033535 000
20705032028438 K033535 000

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