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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 K931335
Device Name SCIMED(R) VENTURE(TM) INFUSION CATHETER
Applicant
Scimed Life Systems, Inc.
2905 Northwest Blvd.
Suite 60
Plymouth,  MN  55441
Applicant Contact DARLENE A THOMETZ
Correspondent
Scimed Life Systems, Inc.
2905 Northwest Blvd.
Suite 60
Plymouth,  MN  55441
Correspondent Contact DARLENE A THOMETZ
Regulation Number870.1210
Classification Product Code
KRA  
Date Received03/16/1993
Decision Date 07/27/1994
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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