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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K092378
Device Name SPECTRANETICS VISISHEATH DILATOR SHEATH
Applicant
Spectranetics Corp.
96 Talamine Ct.
Colorado Springs,  CO  80907
Applicant Contact CHERYL HASTINGS
Correspondent
Spectranetics Corp.
96 Talamine Ct.
Colorado Springs,  CO  80907
Correspondent Contact CHERYL HASTINGS
Regulation Number870.1310
Classification Product Code
DRE  
Date Received08/05/2009
Decision Date 11/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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