TAD INTERMEDIATE & TAD STANDARD 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 Tad Intermediate & Tad Standard Guide Wire.

Pre-market Notification Details

Device IDK882928
510k NumberK882928
Device Name:TAD INTERMEDIATE & TAD STANDARD GUIDE WIRE
ClassificationWire, Guide, Catheter
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View,  CA  94043
ContactKevyn B O'connor
CorrespondentKevyn B O'connor
ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1395 CHARLESTON RD. Mountain View,  CA  94043
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-07-08
Decision Date1988-09-27

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