DOC-TITE(TM) GUIDE WIRE EXTENSION

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 Doc-tite(tm) Guide Wire Extension.

Pre-market Notification Details

Device IDK931171
510k NumberK931171
Device Name:DOC-TITE(TM) GUIDE WIRE EXTENSION
ClassificationWire, Guide, Catheter
Applicant ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara,  CA  95052 -8167
ContactSara Toylo
CorrespondentSara Toylo
ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara,  CA  95052 -8167
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-08
Decision Date1993-06-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08717648013317 K931171 000

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