Hi-Torque Command 18 Guide Wire

Wire, Guide, Catheter

ABBOTT VASCULAR

The following data is part of a premarket notification filed by Abbott Vascular with the FDA for Hi-torque Command 18 Guide Wire.

Pre-market Notification Details

Device IDK152404
510k NumberK152404
Device Name:Hi-Torque Command 18 Guide Wire
ClassificationWire, Guide, Catheter
Applicant ABBOTT VASCULAR 3200 Lakeside Drive Santa Clara,  CA  95054
ContactShu Chi Hsu
CorrespondentShu Chi Hsu
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 Received2015-08-25
Decision Date2015-09-21
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.