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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 K063431
Device Name 15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40
Applicant
SPIRE BIOMEDICAL INC
ONE PATRIOTS PARK
BEDFORD,  MA  01730
Applicant Contact SHEKHAR D NIMKAR
Correspondent
SPIRE BIOMEDICAL INC
ONE PATRIOTS PARK
BEDFORD,  MA  01730
Correspondent Contact SHEKHAR D NIMKAR
Regulation Number876.5540
Classification Product Code
MSD  
Date Received11/13/2006
Decision Date 01/29/2007
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
Recalls CDRH Recalls
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