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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 K870675
Device Name ADDITIONAL 13.4CM. FRENCH CATHETER INSERTION TRAY
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 Number870.1250
Classification Product Code
DQY  
Date Received02/19/1987
Decision Date 04/09/1987
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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