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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 K860898
Device Name SUBCLAVIAN INTRODUCER SET
Applicant
Infusaid Corp.
1400 Providence Hwy.
Norwood,  MA  02062
Applicant Contact VINCENT A BUCCI
Correspondent
Infusaid Corp.
1400 Providence Hwy.
Norwood,  MA  02062
Correspondent Contact VINCENT A BUCCI
Regulation Number870.1340
Classification Product Code
DYB  
Date Received03/10/1986
Decision Date 04/29/1986
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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