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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 K930473
Device Name ONECATH L-CATH CATHETER SYSTEM
Applicant
Luther Medical Products, Inc.
14332 Chambers Rd.
Tustin,  CA  92780
Applicant Contact BARBARA C LUTHER
Correspondent
Luther Medical Products, Inc.
14332 Chambers Rd.
Tustin,  CA  92780
Correspondent Contact BARBARA C LUTHER
Regulation Number880.5970
Classification Product Code
LJS  
Date Received01/28/1993
Decision Date 04/07/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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