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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Balloon Inflation
510(k) Number K895511
Device Name CATHETER BALLOON DILATOR PRESSURE GAUGE
Applicant
Argon Medical Corp.
1445 Flat Creek Rd.
P.O. Box 1970
Athens,  TX  75751
Applicant Contact CLAYTON KOON
Correspondent
Argon Medical Corp.
1445 Flat Creek Rd.
P.O. Box 1970
Athens,  TX  75751
Correspondent Contact CLAYTON KOON
Regulation Number870.1650
Classification Product Code
MAV  
Date Received09/12/1989
Decision Date 02/28/1990
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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