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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Continuous Flush
510(k) Number K021591
Device Name PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
Applicant
Cordis Neurovascular, Inc.
14000 NW 57th Ct.
Miami Lakes,  FL  33014
Applicant Contact MARITZA CELAYA
Correspondent
Cordis Neurovascular, Inc.
14000 NW 57th Ct.
Miami Lakes,  FL  33014
Correspondent Contact MARITZA CELAYA
Regulation Number870.1210
Classification Product Code
KRA  
Date Received05/15/2002
Decision Date 05/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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