TERUMO RADIFOCUS GUIDE WIRE

Wire, Guide, Catheter

TERUMO MEDICAL CORP.

The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Terumo Radifocus Guide Wire.

Pre-market Notification Details

Device IDK863138
510k NumberK863138
Device Name:TERUMO RADIFOCUS GUIDE WIRE
ClassificationWire, Guide, Catheter
Applicant TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton,  MD  21921
ContactHarald Jacoby
CorrespondentHarald Jacoby
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 Received1986-08-15
Decision Date1986-11-20

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