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510(k) K151244

Pre-Formed Guidewire by Lake Region Medical — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2015
Date Received
May 11, 2015
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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  • K133155 — HYDROPHILIC COATED GUIDEWIRE (April 7, 2014)
  • K140485 — MANDREL GUIDEWIRE (March 27, 2014)

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