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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name aspiration thrombectomy catheter
510(k) Number K073519
Device Name QUICKCAT EXTRACTION CATHETER, MODEL 60090-01
Applicant
KENSEY NASH CORP.
735 PENNSYLVANIA DRIVE
EXTON,  PA  19341
Applicant Contact CINDY VARUGHESE
Correspondent
KENSEY NASH CORP.
735 PENNSYLVANIA DRIVE
EXTON,  PA  19341
Correspondent Contact CINDY VARUGHESE
Regulation Number870.5150
Classification Product Code
QEZ  
Date Received12/14/2007
Decision Date 03/28/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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