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510(k) K140485

MANDREL GUIDEWIRE by Lake Region Medical — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2014
Date Received
February 26, 2014
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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  • K140536 — HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT (December 17, 2014)
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  • K140482 — MANDREL GUIDEWIRE (April 8, 2014)
  • K133155 — HYDROPHILIC COATED GUIDEWIRE (April 7, 2014)

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