GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300

Catheter, Percutaneous

MEDTRONIC VASCULAR

The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Gt2 Fusion Guide Wire, Model Ntlhlj180,ntlhls180, Ntlhlj300, Ntlhls300.

Pre-market Notification Details

Device IDK001969
510k NumberK001969
Device Name:GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300
ClassificationCatheter, Percutaneous
Applicant MEDTRONIC VASCULAR 37A CHERRY HILL DR. Danvers,  MA  01923
ContactFred L Boucher
CorrespondentFred L Boucher
MEDTRONIC VASCULAR 37A CHERRY HILL DR. Danvers,  MA  01923
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-06-28
Decision Date2000-08-16

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