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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 K091506
Device Name DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520
Applicant
R4 VASCULAR, INC.
7550 MERIDIAN CIR. N
MAPLE GROVE,  MN  55369
Applicant Contact LAURIE LEWANDOWSKI
Correspondent
R4 VASCULAR, INC.
7550 MERIDIAN CIR. N
MAPLE GROVE,  MN  55369
Correspondent Contact LAURIE LEWANDOWSKI
Regulation Number876.5540
Classification Product Code
MSD  
Date Received05/21/2009
Decision Date 01/08/2010
Decision Substantially Equivalent - Kit (SESK)
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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