MODIFICATION TO SUPERCROSS CATHETER

Catheter, Percutaneous

ABBOTT VASCULAR INC.

The following data is part of a premarket notification filed by Abbott Vascular Inc. with the FDA for Modification To Supercross Catheter.

Pre-market Notification Details

Device IDK014118
510k NumberK014118
Device Name:MODIFICATION TO SUPERCROSS CATHETER
ClassificationCatheter, Percutaneous
Applicant ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City,  CA  94063
ContactSevrina Ciucci
CorrespondentSevrina Ciucci
ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City,  CA  94063
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-12-14
Decision Date2002-01-11
Summary:summary

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