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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 K910486
Device Name 8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER
Applicant
Davol, Inc.
3385 W. 1820
Salt Lake City,  UT  84104
Applicant Contact JACK SPEER
Correspondent
Davol, Inc.
3385 W. 1820
Salt Lake City,  UT  84104
Correspondent Contact JACK SPEER
Regulation Number880.5970
Classification Product Code
LJS  
Date Received02/06/1991
Decision Date 04/19/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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