ARCHER SUPER STIFF GUIDEWIRES

Wire, Guide, Catheter

MEDTRONIC INC.

The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Archer Super Stiff Guidewires.

Pre-market Notification Details

Device IDK101339
510k NumberK101339
Device Name:ARCHER SUPER STIFF GUIDEWIRES
ClassificationWire, Guide, Catheter
Applicant MEDTRONIC INC. 3576 Unocal Place Santa Rosa,  CA  95403
ContactColleen Mullins
CorrespondentColleen Mullins
MEDTRONIC INC. 3576 Unocal Place Santa Rosa,  CA  95403
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-05-12
Decision Date2010-08-31
Summary:summary

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