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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K851195
Device Name VASCULAR ACCESS CATHETER
Applicant
Sil-Med Corp.
700 Warner Blvd.
Taunton,  MA  02780
Applicant Contact ROBERT BRENNAN
Correspondent
Sil-Med Corp.
700 Warner Blvd.
Taunton,  MA  02780
Correspondent Contact ROBERT BRENNAN
Regulation Number880.5970
Classification Product Code
LJS  
Date Received03/26/1985
Decision Date 06/07/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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