ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE

Wire, Guide, Catheter

ADVANCED CARDIOVASCULAR SYSTEMS, INC.

The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Acs Hi-torque Cross-it 400xt Guide Wire.

Pre-market Notification Details

Device IDK992169
510k NumberK992169
Device Name:ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE
ClassificationWire, Guide, Catheter
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. Santa Clara,  CA  95052 -8167
ContactMargaret Anderson
CorrespondentMargaret Anderson
ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. Santa Clara,  CA  95052 -8167
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-06-28
Decision Date1999-10-28
Summary:summary

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