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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K862018
Device Name MICRO PORT
Applicant
Intermedics/Infusaid, Inc.
1400 Providence Hwy.
Norwood,  MA  02062
Applicant Contact VINCENT A BUCCI
Correspondent
Intermedics/Infusaid, Inc.
1400 Providence Hwy.
Norwood,  MA  02062
Correspondent Contact VINCENT A BUCCI
Regulation Number880.5965
Classification Product Code
LJT  
Date Received05/22/1986
Decision Date 09/03/1986
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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