RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD

Wire, Guide, Catheter

TERUMO MEDICAL CORP.

The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Radifocus Glidewire Gt With Gold Coil,glidewire Gold.

Pre-market Notification Details

Device IDK955801
510k NumberK955801
Device Name:RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD
ClassificationWire, Guide, Catheter
Applicant TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton,  MD  21921
ContactKeith M Smith
CorrespondentKeith M Smith
TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton,  MD  21921
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-22
Decision Date1996-02-02

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