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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 TRAIL
HOPKINTON,  MA  01748
Applicant Contact DEBBIE IAMPIETRO
Correspondent
XTRAK MEDICAL INC.
7 TIFFANY TRAIL
HOPKINTON,  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
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