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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 K140799
FOIA Releasable 510(k) K140799
Device Name CELERITY SYSYEM
Applicant
MEDCOMP (MEDICAL COMPONENTS, INC.)
25 FOREST DRIVE
MARLBOROUGH,  MA  01752
Applicant Contact Lorraine M Hanley
Correspondent
MEDCOMP (MEDICAL COMPONENTS, INC.)
25 FOREST DRIVE
MARLBOROUGH,  MA  01752
Correspondent Contact Lorraine M Hanley
Regulation Number880.5970
Classification Product Code
LJS  
Date Received03/31/2014
Decision Date 06/13/2014
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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