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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Hemodialysis, Implanted
510(k) Number K073093
Device Name DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36,
Applicant
Spire Biomedical, Inc.
One Patriots Park
Bedford,  MA  01730
Applicant Contact RAYMOND KELLY
Correspondent
Spire Biomedical, Inc.
One Patriots Park
Bedford,  MA  01730
Correspondent Contact RAYMOND KELLY
Regulation Number876.5540
Classification Product Code
MSD  
Date Received11/01/2007
Decision Date 01/22/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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