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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K954313
Device Name FOCUS PC BALLOON DILATATION CATHETER
Applicant
Cardio-Dynamics, Inc.
13844 Alton Pkwy.,
Suite 140
Irvine,  CA  92718
Applicant Contact MICHAEL CROCKER
Correspondent
Cardio-Dynamics, Inc.
13844 Alton Pkwy.,
Suite 140
Irvine,  CA  92718
Correspondent Contact MICHAEL CROCKER
Regulation Number870.1250
Classification Product Code
LIT  
Date Received09/15/1995
Decision Date 12/01/1995
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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