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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K150201
Device Name Quick-Cross Extreme Support Catheter, Quick-Cross Select Support Catheter
Applicant
Spectranetics, Inc.
9965 Federal Dr.
Colorado Springs,  CO  80921
Applicant Contact Christine Godleski
Correspondent
Spectranetics, Inc.
9965 Federal Dr.
Colorado Springs,  CO  80921
Correspondent Contact Pharoah Garma
Regulation Number870.1250
Classification Product Code
DQY  
Date Received01/29/2015
Decision Date 02/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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