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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 K013473
Device Name XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL
Applicant
Xtrak Medical, Inc.
7 Tiffany Trl.
Hopkonton,  MA  01748
Applicant Contact DEBBIE IAMPIETRO
Correspondent
Xtrak Medical, Inc.
7 Tiffany Trl.
Hopkonton,  MA  01748
Correspondent Contact DEBBIE IAMPIETRO
Regulation Number870.4875
Classification Product Code
MCW  
Date Received10/18/2001
Decision Date 03/06/2002
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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