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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 K001917
Device Name PARODI CATHETER FOR ANGIOGRAPHY (PARCA)
Applicant
ARTERIA MEDICAL SCIENCE, INC.
P.O. BOX 3515
REDMOND,  WA  98073 -3515
Applicant Contact STEVE CHERNOFF
Correspondent
ARTERIA MEDICAL SCIENCE, INC.
P.O. BOX 3515
REDMOND,  WA  98073 -3515
Correspondent Contact STEVE CHERNOFF
Regulation Number870.4450
Classification Product Code
MJN  
Date Received06/23/2000
Decision Date 06/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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