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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 K030742
Device Name POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
Applicant
CRYO VASCULAR SYSTEMS INC.
160 KNOWLES DR.
LOS GATOS,  CA  95032
Applicant Contact KIM TOMPKINS
Correspondent
CRYO VASCULAR SYSTEMS INC.
160 KNOWLES DR.
LOS GATOS,  CA  95032
Correspondent Contact KIM TOMPKINS
Regulation Number870.1250
Classification Product Code
LIT  
Date Received03/10/2003
Decision Date 08/29/2003
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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