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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K902256
Device Name IRRIGATION CATHETER 4, 6 AND 10 FRENCH
Applicant
APPLIED VASCULAR DEVICES, INC.
26051 MERIT CIRCLE, #104
LAGUNA HILLS,  CA  92653
Applicant Contact ROBERT P COOPER
Correspondent
APPLIED VASCULAR DEVICES, INC.
26051 MERIT CIRCLE, #104
LAGUNA HILLS,  CA  92653
Correspondent Contact ROBERT P COOPER
Regulation Number870.1250
Classification Product Code
DQY  
Date Received05/21/1990
Decision Date 02/15/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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