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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 K060016
Device Name THROMCAT THROMBECTOMY CATHETER SYSTEM
Applicant
Kensey Nash Corp.
735 Pennsylvania Ave.
Exton,  PA  19341
Applicant Contact JENNIFER J BOSLEY
Correspondent
Kensey Nash Corp.
735 Pennsylvania Ave.
Exton,  PA  19341
Correspondent Contact JENNIFER J BOSLEY
Regulation Number870.4875
Classification Product Code
MCW  
Date Received01/03/2006
Decision Date 04/25/2006
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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