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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 Occluding, Temporary
510(k) Number K964390
Device Name CHASE VESSEL OCCLUDER
Applicant
Chase Medical, Inc.
1876 Firman Dr.
Richardson,  TX  75081
Applicant Contact BERT DAVIS
Correspondent
Chase Medical, Inc.
1876 Firman Dr.
Richardson,  TX  75081
Correspondent Contact BERT DAVIS
Regulation Number870.4450
Classification Product Code
MJN  
Date Received11/04/1996
Decision Date 01/31/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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