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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 K021704
Device Name VAXCEL PICC WITH PASV VALVE TECHNOLOGY
Applicant
CATHETER INNOVATIONS, INC.
3598 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Applicant Contact ROGER L RICHINS
Correspondent
CATHETER INNOVATIONS, INC.
3598 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Correspondent Contact ROGER L RICHINS
Regulation Number880.5970
Classification Product Code
LJS  
Date Received05/23/2002
Decision Date 06/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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