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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Subclavian
510(k) Number K901133
Device Name DURACATH
Applicant
Impra, Inc.
1625 W. 3rd St.
P.O. Box 1740
Tempe,  AZ  85281
Applicant Contact BILL COLONE
Correspondent
Impra, Inc.
1625 W. 3rd St.
P.O. Box 1740
Tempe,  AZ  85281
Correspondent Contact BILL COLONE
Regulation Number876.5540
Classification Product Code
LFJ  
Date Received03/12/1990
Decision Date 06/08/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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