HI-TORQUE PROCEED Guide Wire Family

Wire, Guide, Catheter

Abbott Vascular

The following data is part of a premarket notification filed by Abbott Vascular with the FDA for Hi-torque Proceed Guide Wire Family.

Pre-market Notification Details

Device IDK201834
510k NumberK201834
Device Name:HI-TORQUE PROCEED Guide Wire Family
ClassificationWire, Guide, Catheter
Applicant Abbott Vascular 3200 Lakeside Drive Santa Clara,  CA  95094
ContactCharlotte Pullman
CorrespondentCharlotte Pullman
Abbott Vascular 3200 Lakeside Drive Santa Clara,  CA  95094
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-02
Decision Date2020-07-30

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