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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 K003925
Device Name PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS
Applicant
CORDIS NEUROVASCULAR, INC.
14000 N.W. 57TH CT.
MIAMI LAKES,  FL  33014
Applicant Contact Amarilys Machado
Correspondent
CORDIS NEUROVASCULAR, INC.
14000 N.W. 57TH CT.
MIAMI LAKES,  FL  33014
Correspondent Contact Amarilys Machado
Regulation Number870.1210
Classification Product Code
KRA  
Date Received12/20/2000
Decision Date 01/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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