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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 K130637
Device Name JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM
Applicant
Medrad, Inc.
10801 120th Ave. NE
Kirkland,  WA  98033
Applicant Contact BRIT BAIRD
Correspondent
Medrad, Inc.
10801 120th Ave. NE
Kirkland,  WA  98033
Correspondent Contact BRIT BAIRD
Regulation Number870.4875
Classification Product Code
MCW  
Date Received03/11/2013
Decision Date 04/10/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Clinical Trials NCT00676494
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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