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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, diagnostic
510(k) Number K061733
FOIA Releasable 510(k) K061733
Device Name ANGIODYNAMICS SOFT-VU AND MARINER HYDROPHILIC COATED ANGIOGRAPHIC CATHETER
Applicant
ANGIODYNAMICS, INC.
603 QUEENSBURY AVE.
QUEENSBURY,  NY  12804
Applicant Contact TERI JUCKETT
Correspondent
ANGIODYNAMICS, INC.
603 QUEENSBURY AVE.
QUEENSBURY,  NY  12804
Correspondent Contact TERI JUCKETT
Regulation Number870.1200
Classification Product Code
DQO  
Date Received06/20/2006
Decision Date 08/24/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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