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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K924562
Device Name CATHETER INTRODUCER
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 Number870.1340
Classification Product Code
DYB  
Date Received09/09/1992
Decision Date 02/25/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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