HI-TORQUE InfilTrac 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 Infiltrac Guide Wire Family.

Pre-market Notification Details

Device IDK193126
510k NumberK193126
Device Name:HI-TORQUE InfilTrac 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 Received2019-11-12
Decision Date2019-12-11

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