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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K813019
Device Name PERCUTANEOUS INTRODUCER: SELDINGER STYLE
Applicant
Dip, Inc.
Walker,  MI  49504
Applicant Contact James DeVries
Correspondent
Dip, Inc.
Walker,  MI  49504
Correspondent Contact James DeVries
Regulation Number870.1340
Classification Product Code
DYB  
Date Received10/27/1981
Decision Date 11/16/1981
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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