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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K980278
Device Name URESIL VASCU-FLO INFUSION CATHETER
Applicant
Uresil Corp.
5418 W. Touhy Ave.
Skokie,  IL  60077
Applicant Contact MATTHEW CURTIS
Correspondent
Uresil Corp.
5418 W. Touhy Ave.
Skokie,  IL  60077
Correspondent Contact MATTHEW CURTIS
Regulation Number870.1250
Classification Product Code
DQY  
Date Received01/26/1998
Decision Date 11/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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