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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K963806
Device Name CLAMPLESS VALVED CATHETER - TUNNELED (CVC-T)
Applicant
BMW MEDICAL, INC.
3598 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104 -4959
Applicant Contact PHI TRIOLO
Correspondent
BMW MEDICAL, INC.
3598 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104 -4959
Correspondent Contact PHI TRIOLO
Regulation Number880.5970
Classification Product Code
LJS  
Date Received09/23/1996
Decision Date 12/12/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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