FDA.report

510(k) K251596

Device
Lunderquist Extra Stiff Wire Guide
Applicant
William Cook Europe Aps
510(k) number
K251596
Product code
DQX
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-09
Date received
2025-05-27
Regulation
870.1330
Classification name
Wire, Guide, Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Mie Dyrholm
Address
Sandet 6 Bjaeverskov DK 4632 4632

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code DQX

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K250031Amplatzer GuidewireABBOTT MEDICAL2025-10-03
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K241962CrossloopAsahi Intecc Co., Ltd.2025-03-27
K242597CROSSLEAD 0.018inchAsahi Intecc Co., Ltd.2025-03-05
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