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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peripheral, Atherectomy
510(k) Number K133023
Device Name JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6
Applicant
Medrad, Inc.
9055 Evergreen Blvd. NW
Minneapolis,  MN  55433
Applicant Contact ARMA RACIC
Correspondent
Medrad, Inc.
8880 Evergreen Blvd. NW
Minneapolis,  MN  55433
Correspondent Contact George Lucas
Regulation Number870.4875
Classification Product Code
MCW  
Subsequent Product Code
QEW  
Date Received09/26/2013
Decision Date 08/27/2014
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
Recalls CDRH Recalls
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