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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Flow Directed
510(k) Number K963248
Device Name FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)
Applicant
J-Lloyd Medical, Inc.
415 Commerce Ln., Suite 7
West Berlin,  NJ  08091
Applicant Contact JAMES L SKAGGS, SR.
Correspondent
J-Lloyd Medical, Inc.
415 Commerce Ln., Suite 7
West Berlin,  NJ  08091
Correspondent Contact JAMES L SKAGGS, SR.
Regulation Number870.1240
Classification Product Code
DYG  
Date Received08/19/1996
Decision Date 02/03/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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