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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 K945904
Device Name SCIMED(R) VENTURE(TM) II INFUSION CATHETER
Applicant
Scimed Peripheral Interventions
One Scimed Pl.
Maple Grove,  MN  55311
Applicant Contact DARLENE A THOMETZ
Correspondent
Scimed Peripheral Interventions
One Scimed Pl.
Maple Grove,  MN  55311
Correspondent Contact DARLENE A THOMETZ
Regulation Number870.1210
Classification Product Code
KRA  
Date Received12/02/1994
Decision Date 05/19/1995
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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