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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 K872163
Device Name IMPRA DUAL LUMEN SUBCLAVIAN 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 Number870.1250
Classification Product Code
DQY  
Date Received06/05/1987
Decision Date 10/30/1987
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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