HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05

Wire, Guide, Catheter

Abbott Vascular

The following data is part of a premarket notification filed by Abbott Vascular with the FDA for Hi-torque Flex-t Guide Wire, Models 1012067-01, 02, 03, 04 And 05.

Pre-market Notification Details

Device IDK083738
510k NumberK083738
Device Name:HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05
ClassificationWire, Guide, Catheter
Applicant Abbott Vascular 3200 Lakeside Drive Santa Clara,  CA  95054
ContactNadine Smith
CorrespondentNadine Smith
Abbott Vascular 3200 Lakeside Drive Santa Clara,  CA  95054
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-12-16
Decision Date2009-03-11
Summary:summary

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