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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 K920755
Device Name L-CATH PEEL AWAY SYSTEM CATHETER
Applicant
LUTHER MEDICAL PRODUCTS, INC.
14332 CHAMBERS RD.
TUSTIN,  CA  92780 -6912
Applicant Contact BARBARA C LUTHER
Correspondent
LUTHER MEDICAL PRODUCTS, INC.
14332 CHAMBERS RD.
TUSTIN,  CA  92780 -6912
Correspondent Contact BARBARA C LUTHER
Regulation Number880.5970
Classification Product Code
LJS  
Date Received02/19/1992
Decision Date 06/07/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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