LUNDERQUIST WIRE GUIDE; DC WIRE GUIDE

Wire, Guide, Catheter

WILLIAM COOK EUROPE APS

The following data is part of a premarket notification filed by William Cook Europe Aps with the FDA for Lunderquist Wire Guide; Dc Wire Guide.

Pre-market Notification Details

Device IDK061670
510k NumberK061670
Device Name:LUNDERQUIST WIRE GUIDE; DC WIRE GUIDE
ClassificationWire, Guide, Catheter
Applicant WILLIAM COOK EUROPE APS SANDET 6, DK-4632 Bjaeverskov,  DK
ContactTina H Anderson
CorrespondentTina H Anderson
WILLIAM COOK EUROPE APS SANDET 6, DK-4632 Bjaeverskov,  DK
Product CodeDQX  
CFR Regulation Number870.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-14
Decision Date2007-01-19
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.