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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, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K142889
FOIA Releasable 510(k) K142889
Device Name Celerity PICC Tip Confirmation System
Applicant
ANGIODYNAMICS, INC.
26 FOREST STREET
MARLBOROUGH,  MA  01751
Applicant Contact Michael Hanley
Correspondent
ANGIODYNAMICS, INC.
26 FOREST STREET
MARLBOROUGH,  MA  01751
Correspondent Contact Michael Hanley
Regulation Number880.5970
Classification Product Code
LJS  
Date Received10/03/2014
Decision Date 01/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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