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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K143561
Device Name ELM PTA Balloon Dilatation Catheter
Applicant
O'Connell Regulatory Consultants, Inc.
5 Timber Ln.
North Reading,  MA  01864
Applicant Contact Maureen O'Connell
Correspondent
O'Connell Regulatory Consultants, Inc.
5 Timber Ln.
North Reading,  MA  01864
Correspondent Contact Maureen O'Connell
Regulation Number870.1250
Classification Product Code
LIT  
Date Received12/16/2014
Decision Date 05/19/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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