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510(k) K133631

LEXIPLIANT DILATOR SHEATH SET by Spectranetics Corporation — Product Code DRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2014
Date Received
November 26, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, For Percutaneous Catheterization
Device Class
Class II
Regulation Number
870.1310
Review Panel
CV
Submission Type

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