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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 K851078
Device Name HDC SILCATH SUBCLAVIAN CATHETER PERCUTANEOUS INSER
Applicant
Hdc Corp.
2551 Casey Ave.
Mountain View,  CA  94043
Applicant Contact STEPHEN K PARKS
Correspondent
Hdc Corp.
2551 Casey Ave.
Mountain View,  CA  94043
Correspondent Contact STEPHEN K PARKS
Regulation Number870.1340
Classification Product Code
DYB  
Date Received03/18/1985
Decision Date 04/19/1985
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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