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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter Introducer Kit
510(k) Number K093257
Device Name TORQMAX SHEATH GRIP ACCESSORY
Applicant
Spectranetics Corp.
9965 Federal Dr.
Colorado Springs,  CO  80921
Applicant Contact BRANDON HANSEN
Correspondent
Spectranetics Corp.
9965 Federal Dr.
Colorado Springs,  CO  80921
Correspondent Contact BRANDON HANSEN
Regulation Number870.1340
Classification Product Code
OFC  
Date Received10/19/2009
Decision Date 03/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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