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FDA 510(k) Application Details - K133631
Device Classification Name
Dilator, Vessel, For Percutaneous Catheterization
More FDA Info for this Device
510(K) Number
K133631
Device Name
Dilator, Vessel, For Percutaneous Catheterization
Applicant
SPECTRANETICS CORPORATION
9965 FEDERAL DRIVE
COLORADO SPRINGS, CO 80921-3617 US
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Contact
STACEY A STRAND
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Regulation Number
870.1310
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Classification Product Code
DRE
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More FDA Info for this Product Code
Date Received
11/26/2013
Decision Date
03/27/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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