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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Catheter
510(k) Number K884375
Device Name TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER
Applicant
Argon Medical Corp.
1445 Flat Creek Rd.
P.O. Box 1970
Athens,  TX  75751
Applicant Contact BRISTER, P.E.
Correspondent
Argon Medical Corp.
1445 Flat Creek Rd.
P.O. Box 1970
Athens,  TX  75751
Correspondent Contact BRISTER, P.E.
Regulation Number870.1300
Classification Product Code
DQR  
Date Received10/18/1988
Decision Date 01/11/1989
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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