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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K855201
Device Name BARD PARKER PERFUSION CATHETER
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
Mack Centre Dr.
P.O.Box 2224
Paramus,  NJ  07652
Applicant Contact RUSSELL ARNSBERGER
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
Mack Centre Dr.
P.O.Box 2224
Paramus,  NJ  07652
Correspondent Contact RUSSELL ARNSBERGER
Regulation Number870.1250
Classification Product Code
DQY  
Date Received12/27/1985
Decision Date 04/29/1986
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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