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510(k) K251596

Lunderquist Extra Stiff Wire Guide by William Cook Europe Aps — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2025
Date Received
May 27, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type

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  • K171712 — Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect (August 7, 2017)
  • K161813 — Frova Intubating Introducer (May 19, 2017)

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