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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 K040830
Device Name PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
Applicant
NUMED, INC.
2880 MAIN ST.
HOPKINTON,  NY  12965
Applicant Contact NICHELLE R LAFLESH
Correspondent
NUMED, INC.
2880 MAIN ST.
HOPKINTON,  NY  12965
Correspondent Contact NICHELLE R LAFLESH
Regulation Number870.1200
Classification Product Code
DQO  
Subsequent Product Codes
DQY   DXF   LIT   MJN   OMZ  
Date Received03/31/2004
Decision Date 06/18/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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