ACS HI-TORQUE RULER GUIDE WIRE

Wire, Guide, Catheter

GUIDANT CORP.

The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Acs Hi-torque Ruler Guide Wire.

Pre-market Notification Details

Device IDK972290
510k NumberK972290
Device Name:ACS HI-TORQUE RULER GUIDE WIRE
ClassificationWire, Guide, Catheter
Applicant GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara,  CA  95054 -2807
ContactSue Silavin
CorrespondentSue Silavin
GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara,  CA  95054 -2807
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-19
Decision Date1997-09-17
Summary:summary

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