HI-TORQUE TurnTrac 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 Turntrac Guide Wire Family.

Pre-market Notification Details

Device IDK173795
510k NumberK173795
Device Name:HI-TORQUE TurnTrac Guide Wire Family
ClassificationWire, Guide, Catheter
Applicant Abbott Vascular 3200 Lakeside Drive Santa Clara,  CA  95054
ContactAniket Khakhadiya
CorrespondentAniket Khakhadiya
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 Received2017-12-14
Decision Date2018-01-12
Summary:summary

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