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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 K812964
Device Name INTRODUCER, PERCUTANEOUS SELDINGER
Applicant
Triad Medical Division
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Triad Medical Division
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number870.1340
Classification Product Code
DYB  
Date Received10/22/1981
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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