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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 K042858
Device Name 55CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS
Applicant
SPIRE BIOMEDICAL, INC.
ONE PATRIOTS PARK
BEDFORD,  MA  01730 -2396
Applicant Contact DONALD FICKETT
Correspondent
SPIRE BIOMEDICAL, INC.
ONE PATRIOTS PARK
BEDFORD,  MA  01730 -2396
Correspondent Contact DONALD FICKETT
Regulation Number876.5540
Classification Product Code
MSD  
Date Received10/15/2004
Decision Date 12/03/2004
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
Recalls CDRH Recalls
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