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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K946189
Device Name INTROPORT(TM) CATHETER MODEL #1000(ICT)
Applicant
Lifequest Medical, Inc.
9601 Mcallister Fwy.
Suite 1120
San Antonio,  TX  78216
Applicant Contact DAVID COLLETTE
Correspondent
Lifequest Medical, Inc.
9601 Mcallister Fwy.
Suite 1120
San Antonio,  TX  78216
Correspondent Contact DAVID COLLETTE
Regulation Number880.5965
Classification Product Code
LJT  
Date Received12/20/1994
Decision Date 07/06/1995
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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