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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 K951503
Device Name CVD BULLETT HI-FLO INFUSION CATHETER
Applicant
Cardiovascular Dynamics, Inc.
15 Hammond
Suite 307
Irvine,  CA  92718
Correspondent
Cardiovascular Dynamics, Inc.
15 Hammond
Suite 307
Irvine,  CA  92718
Regulation Number870.1210
Classification Product Code
KRA  
Date Received03/28/1995
Decision Date 05/04/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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