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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 K001633
Device Name LIFESITE HEMODIALYSIS ACCESS SYSTEM/CANNULA EXCHANGE, MODEL LHAS14120 & LHCEK0000
Applicant
Vasca, Inc.
3 Highwood Dr.
Tewksburt,  MA  01876
Applicant Contact DOUGLAS E FERGUSON
Correspondent
Vasca, Inc.
3 Highwood Dr.
Tewksburt,  MA  01876
Correspondent Contact DOUGLAS E FERGUSON
Regulation Number876.5540
Classification Product Code
MSD  
Date Received05/26/2000
Decision Date 08/24/2000
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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