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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 K883592
Device Name IMPRA DUAL LUMEN SUBCLAVIAN - FEMORAL CATHETER
Applicant
Impra, Inc.
1625 W. 3rd St.
P.O. Box 1740
Tempe,  AZ  85281
Applicant Contact JAMES M MCHANEY
Correspondent
Impra, Inc.
1625 W. 3rd St.
P.O. Box 1740
Tempe,  AZ  85281
Correspondent Contact JAMES M MCHANEY
Regulation Number876.5540
Classification Product Code
LFJ  
Date Received08/23/1988
Decision Date 12/08/1988
Decision Substantially Equivalent - With Drug (SESD)
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
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