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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Septostomy
510(k) Number K011557
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 Number870.5175
Classification Product Code
DXF  
Subsequent Product Codes
DQO   LIT  
Date Received05/21/2001
Decision Date 07/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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