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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Femoral
510(k) Number K865096
Device Name NEW SECOND FRENCH SIZE MAHURKAR CATHETER
Applicant
Quinton, Inc.
2121 Terry Ave.
Seattle,  WA  98121
Applicant Contact MARY-LEE DONOGHUE
Correspondent
Quinton, Inc.
2121 Terry Ave.
Seattle,  WA  98121
Correspondent Contact MARY-LEE DONOGHUE
Regulation Number876.5540
Classification Product Code
LFK  
Date Received12/30/1986
Decision Date 02/18/1987
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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