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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 K040509
Device Name ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40
Applicant
SPIRE BIOMEDICAL INC
ONE PATRIOTS PARK
BEDFORD,  MA  01730
Applicant Contact DONALD FICKETT
Correspondent
SPIRE BIOMEDICAL INC
ONE PATRIOTS PARK
BEDFORD,  MA  01730
Correspondent Contact DONALD FICKETT
Regulation Number876.5540
Classification Product Code
MSD  
Date Received02/27/2004
Decision Date 04/19/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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